L.S. 454.15 Regolamenti dwar Strumenti ta' Kejl

(1)The title of these regulations is the Measuring Instruments Regulations. Citation and scope.

(2)These regulations implement Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (recast).

(3)These regulations apply to the measuring instruments defined in the instrument-specific Schedules III to XII (hereinafter referred to as "instrument-specific Schedules") concerning water meters (MI-001), gas meters and volume conversion devices (MI002), active electrical energy meters (MI-003), thermal energy meters (MI-004), measuring systems for continuous and dynamic measurement of quantities of liquids other than water (MI-005), automatic weighing instruments (MI-006), taxi-meters (MI-007), material measures (MI-008), dimensional measuring instruments (MI-009) and exhaust gas analysers (MI-010).

(4)These regulations shall apply with respect to requirements for electromagnetic immunity within the meaning of Article 2

(3)of Directive 2014/30/EU of the European Parliament and of the Council

(1)which provisions continue to apply with regard to emission requirements. 2. In these regulations, unless the context otherwise requires: "accreditation" means accreditation as defined in Article 2 of Regulation (EC) no 765/2008; "authorised representative" means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks; "Authority" means the Standards and Metrology Institute of the Malta Competition and Consumer Affairs Authority; "CE marking" means a marking by which the manufacturer indicates that the measuring instrument is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing; "conformity assessment" means the process demonstrating whether the essential requirements of these regulations relating to a measuring instrument have been fulfilled; "conformity assessment body" means a body that performs conformity assessment activities including calibration, testing, * see regulation 1

(2)of these Regulations, as originally promulgated. Definitions. 2 [ S.L.454.15 MEASURING INSTRUMENTS certification and inspection. "distributor" means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a measuring instrument available on the market; "economic operators" means the manufacturer, the authorised representative, the importer and the distributor; "harmonised standard" means harmonised standard as defined in regulation 2 of Regulation (EU) No 1025/2012; "importer" means any natural or legal person established within the Union who places a measuring instrument from a third country on the Union market; "legal metrological control" means the control of the measurement tasks intended for the field of application of a measuring instrument, for reasons of public interest, public health, public safety, public order, protection of the environment, levying of taxes and duties, protection of the consumers and fair trading; "making available on the m arket " m eans any supply of a measuring instrument for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; "manufacturer" means any natural or legal person who manufactures a measuring instrument or has a measuring instrument designed or manufactured, and markets that measuring instrument under his name or trade mark or puts it into use for his own purposes; "measuring instrument" means any device or system with a measurement according to the provisions of these regulations; "Member State" means a Member State of the European Union; "Minister" means the Minister responsible for standards and metrology and includes, to the extent of the authority given, any person authorised by the Minister to act in that behalf for any purpose of these regulations; S.L. 419.

1. "National Accreditation Board (Malta)" means the National Accreditation Board (Malta) established in terms of regulation 3 of the National Accreditation Board (Malta) (Establishment) Regulations; "normative document" means a document containing technical specifications adopted by the International Organisation of Legal Metrology*; "placing on the market" means the first making available of a measuring instrument on the Union market; "putting into use" means the first use of a measuring instrument intended for the end-user for t he purposes for which it was intended; "recall" means any measure aimed at achieving the return of a * https://www.oiml.org/en MEASURING INSTRUMENTS [ S.L.454.15 measuring instrument that has already been made available to the end-user; "sub-assembly" means a hardware device, mentioned as such in the instrument-specific schedules that functions independently and m a k e s up a m e a s u r in g i n s t ru m e n t t o ge th e r wi t h o th e r su bassemblies with which it is compatible, or with a measuring instrument with which it is compatible; "technical specification" means a document that prescribes technical requirements to be fulfilled by a measuring instrument; "the Union" means the European Union as referred to article 2 of the European Union Act; Cap.
2. "Union harmonisation legislation" means any Union legislation harmonising the conditions for the marketing of products; and "withdrawal" means any measure aimed at preventing a measuring instrument in the supply chain from being made available on the market. 3.

(1)Where instrument-specific schedules lay down the essential requirements for sub-assemblies, these regulations shall mutatis mutandis apply to such sub-assemblies. Applicability to sub-assemblies.

(2)Sub-assemblies and measuring instruments may be assessed independently and separately for the purpose of establishing conformity.

1. The penalties applicable for the infringement of the provisions of Regulation (EU) No 167/2013 shall be those provided for in Part IV of the Product Safety Act. Penalties.
2. These regulations establish the requirements that measuring instruments have to satisfy with a view to their being made available on the market and, or put into use for the measuring tasks referred to in these regulations. Subject matter. 6.

(1)The Authority may prescribe the use of measuring instruments for measuring tasks, where they consider it justified for reasons of public interest, public health, public safety, public order, protection of the environment, protection of consumers, levying of taxes and duties and fair trading. Optionality. Cap. 427.

(2)If the Authority does not prescribe such use, it shall communicate the reasons therefore to the Commission and the other Member States. 7.

(1)A measuring instrument shall meet the essential requirements set out in Schedule I and in the relevant instrumentspecific Schedules.

(2)For the correct use of the instrument, the information referred to in point 9 of Schedule I or in the relevant instrumentspecific Schedules may be provided in at least English and, or Maltese. Essential requirements. 3 4 [ S.L.454.15 Making available on the market and putting into use. MEASURING INSTRUMENTS 8.

(1)The making available on the market and, or putting into use of any measuring instrument that satisfies the requirements of these regulations shall not be impeded for reasons covered by these regulations.

(2)The Authority shall take all appropriate measures to ensure that measuring instruments are made available on the market and/or put into use only if they satisfy the requirements of these regulations.

(3)A measuring instrument may be required to satisfy the provisions governing its putting into use that are justified by local climatic conditions. In such a case, the Authority shall choose appropriate upper and lower temperature limits from Table 1 of Schedule I and may specify humidity conditions (condensing or non-condensing) and whether the intended location of use is open or closed.

(4)When different accuracy classes are defined for a measuring instrument: (

1. a)the instrument-specific Schedules under the heading ‘Putting into use’ may indicate the accuracy classes to be used for specific applications; (
2. b)in all other cases the Authority may determine the accuracy classes to be used for specific applications within the classes defined, subject to allowing the use of all accuracy classes on its territory; (
3. c)for the purposes of paragraph (
4. a)or paragraph (b), measuring instruments of a better accuracy class may be used if the owner so chooses.

(5)At trade fairs, exhibitions, demonstrations or similar events, the showing of measuring instruments not in conformity with these regulations shall not be prevented: Provided that a visible sign clearly indicates their nonconformity and their non-availability for making available on the market and/or putting into use until they are brought into conformity. Obligations of manufacturers. 9.

(1)When placing their measuring instruments on the market and, or putting them into use, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Schedule I and in the relevant instrument-specific Schedules.

(2)Manufacturers shall draw up the technical documentation referred to in regulation 10 and carry out the relevant conformity assessment procedure referred to in regulation 17 or have it carried out. Compliance of a measuring instrument. 10.

(1)Where compliance of a measuring instrument with the applicable requirements of these regulations has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking and the supplementary metrology marking. MEASURING INSTRUMENTS [ S.L.454.15

(2)Manufacturers shall keep the technical documentation and the EU declaration of conformity for ten years after the measuring instrument has been placed on the market.

(3)Manufacturers shall ensure that procedures are in place for series production to remain in conformity with these regulations. Changes in measuring instrument design or characteristics and changes in the harmonised standards, normative documents or in other technical specifications by reference to which conformity of a measuring instrument is declared shall be adequately taken into account.

(4)When deemed appropriate with regard to the performance of a measuring instrument, manufacturers shall carry out sample testing of measuring instruments made available on the market, investigate and, if necessary, keep a register of complaints, of nonconforming measuring instruments and measuring instrument recalls, and shall keep distributors informed of any such monitoring.

(5)Manufacturers shall ensure that measuring instruments which they have placed on the market bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the measuring instrument does not allow it, that the required information is provided in a document accompanying t h e m e a s u r i n g i n s t r u m e n t a n d o n t h e p a c k ag i n g , i f a n y, i n accordance with point 9.2 of Schedule I.

(6)Manufacturers shall indicate on the measuring instrument their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, in a document accompanying the measuring instrument and on the packaging, if any, in accordance with point 9.2 of Schedule I. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in at least English and, or Maltese.

(7)Manufacturers shall ensure that the measuring instrument which they have placed on the market is accompanied by a copy of the EU Declaration of conformity and by instructions and information in accordance with point 9.3 of Schedule I, in at least English and, or Maltese. Such instructions and information, as well as any labelling, shall be clear, understandable and intelligible.

(8)Manufacturers who consider or have reason to believe that a measuring instrument which they have placed on the market is not in conformity with these regulations shall immediately take the corrective measures necessary to bring that measuring instrument into conformity, to withdraw i t or r ecall it, if a ppropriate. Furthermore, where the measuring instrument presents a risk, manufacturers shall immediately inform the Authority in which they made the measuring instrument available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

(9)Manufacturers shall, further to a reasoned request from the Authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity 5 6 [ S.L.454.15 MEASURING INSTRUMENTS of the measuring instrument with these regulations, in at least English and, or Maltese. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by measuring instruments which they have placed on the market. Authorised representatives. 11.

(1)A manufacturer may, by a written mandate, appoint an authorised representative.

(2)The obligations laid down in regulation 9

(1)and the obligation to draw up technical documentation referred to in regulation 9

(2)shall not form part of the authorised representative’s mandate.

(3)An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following: (

1. a)keep the EU declaration of conformity and the technical documentation at the disposal of the Authority for ten years after the measuring instrument has been placed on the market; (
2. b)further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a measuring instrument; (
3. c)cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by measuring instruments covered by their mandate. Obligations of importers. 12.

(1)Importers shall place only compliant measuring instruments on the market.

(2)Before placing a measuring instrument on the market and, or putting a measuring instrument into use importers shall ensure that the appropriate conformity assessment procedure referred to in regulation 17 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the measuring instrument bears the CE marking and the supplementary metrology marking and is accompanied by a copy of the EU declaration of conformity and the required documents, and that the manufacturer has complied with the requirements set out in regulation 10

(5)and

(6).

(3)Where an importer considers or has reason to believe that a measuring instrument is not in conformity with the essential requirements set out in Schedule I and in the relevant instrumentspecific Schedules, he shall not place the measuring instrument on t he m ark et o r pu t it i nto u se unt il i t has be en brou gh t in to conformity. Furthermore, where the measuring instrument presents a risk, the importer shall inform the manufacturer and the Authority to that effect.

(4)Importers shall indicate on the measuring instrument their name, registered trade name or registered trade mark and the postal MEASURING INSTRUMENTS [ S.L.454.15 address at which they can be contacted or, where that is not possible, in a document accompanying the measuring instrument and on its packaging, if any, in accordance with point 9.2 of Schedule I. The contact details shall be in at least English and, or Maltese.

(5)Importers shall ensure that the measuring instrument is accompanied by instructions and information in accordance with point 9.3 of Schedule I, in at least English and, or Maltese.

(6)Importers shall ensure that, while a measuring instrument is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements set out in Schedule I and in the relevant instrument-specific Schedules.

(7)When deemed appropriate with regard to the performance of a measuring instrument, importers shall carry out sample testing of measuring instruments made available on the market, investigate, and, if necessary, keep a register of complaints, of nonconforming measuring instruments and measuring instrument recalls, and shall keep distributors informed of any such monitoring.

(8)Importers who consider or have reason to believe that a measuring instrument which they have placed on the market is not in conformity with these regulations shall immediately take the corrective measures necessary to bring that measuring instrument into conformity, to withdraw i t or r ecall it, if a ppropriate. Furthermore, where the measuring instrument presents a risk, importers shall immediately inform the Authority in which they made the measuring instrument available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

(9)Importers shall, for ten years after the measuring instrument has been placed on the market keep a copy of the EU declaration of conformity at the disposal of the Authority and ensure that the technical documentation can be made available to those authorities, upon request.

(10)Importers shall, further to a reasoned request from the Authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a measuring instrument in at least English and, or Maltese. They shall cooperate with the Authority, at its request, on any action taken to eliminate the risks posed by measuring instruments which they have placed on the market. 13.

(1)When making a measuring instrument available on the market and, or putting it into use, distributors shall act with due care in relation to the requirements of these regulations.

(2)Before making a measuring instrument available on the market and, or putting a measuring instrument into use distributors shall verify that the measuring instrument bears the CE marking and the supplementary metrology marking, that it is accompanied by the EU declaration of conformity, by the required documents and by instructions and information in accordance with point 9.3 of Obligations of distributors. 7 8 [ S.L.454.15 MEASURING INSTRUMENTS Schedule I, in at least English and, or Maltese, or put into use, and that the manufacturer and the importer have complied with the requirements set out in regulation 10

(5)and

(6)and regulation 12

(3)respectively.

(3)Where a distributor considers or has reason to believe that a measuring instrument is not in conformity with the essential requirements set out in Schedule I and in the relevant instrumentspecific Schedules, he shall not make the measuring instrument available on the market or put it into use, until it has been brought into conformity. Furthermore, where the measuring instrument presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the Authority.

(4)Distributors shall ensure that, while a measuring instrument is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements set out in Schedule I and in the relevant instrument-specific Schedules.

(5)Distributors who consider or have reason to believe that a measuring instrument which they have made available on the market or put into use is not in conformity with these regulations shall make sure that the corrective measures necessary to bring that measuring instrument into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the measuring instrument presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the measuring instrument available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

(5)Distributors shall, further to a reasoned request from the Authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a measuring instrument. They shall cooperate with the Authority, at its request, on any action taken to eliminate the risks posed by measuring instruments which they have made available on the market. Cases in which obligations of manufacturers apply to importers and distributors.

1. An importer or distributor shall be considered a manufacturer for the purposes of these regulations and he shall be subject to the obligations of the manufacturer under regulation 9, where he places a measuring instrument on the market under his name or trade mark or modifies a measuring instrument already placed on the market in such a way that compliance with these regulations may be affected. Identification of economic operators.
2. Economic operators shall, on request, identify the following to the Authority (a) any economic operator who has supplied them with a measuring instrument; (b) any economic operator to whom they have supplied a measuring instrument; (c) economic operators shall be able to present the information referred to in paragraph (a) for ten years MEASURING INSTRUMENTS [ S.L.454.15 after they have been supplied with the measuring instrument and for ten years after they have supplied the measuring instrument. 16.

(1)Measuring instruments which are in conformity with harmonised standards or parts thereof shall be presumed to be in conformity with the essential requirements set out in Schedule I and in the relevant instrument-specific Schedules covered by those standards or parts thereof. Presumption of conformity of measuring instruments.

(2)Measuring instruments which are in conformity with parts of normative documents shall be presumed to be in conformity with the essential requirements set out in Schedule I and in the relevant instrument-specific Schedules covered by those parts of normative documents.

(3)A manufacturer may choose to use any technical solution that complies with the essential requirements set out in Schedule I and in the relevant instrument-specific Schedules. In addition, to benefit from the presumption of conformity, the manufacturer must correctly apply solutions mentioned either in the relevant harmonised standards or in the normative documents referred to in sub-regulations

(1)and

(2).

(4)Compliance shall be presumed with the appropriate tests mentioned in regulation 18

(3)if the corresponding test programme has been performed in accordance with the relevant documents mentioned in sub-regulations

(1),

(2)and

(3)and if the test results ensure compliance with the essential requirements. 17.

(1)Conformity assessment of a measuring instrument with the applicable essential requirements shall be carried out by the application, at the choice of the manufacturer, of one of the conformity assessment procedures listed in the relevant instrumentspecific Schedules. Conformity assessment procedures.

(2)The conformity assessment procedures are set out in Schedule II. Records and correspondence relating to conformity assessment procedures shall be drawn up in the at least English language where the notified body carrying out the conformity assessment procedures is established, or in a language accepted by that body. 18.

(1)The technical documentation shall render the design, manufacture and operation of the measuring instrument intelligible and shall permit an assessment of its conformity with the applicable requirements of these regulations.

(2)The technical documentation shall be sufficiently detailed to ensure compliance with the following requirements: (

1. a)the definition of the metrological characteristics; (
2. b)the reproducibility of the metrological performances of produced measuring instruments when properly adjusted using appropriate intended means; (
3. c)the integrity of the measuring instrument.

(3)The technical documentation shall insofar as relevant for Technical documentation. 9 10 [ S.L.454.15 MEASURING INSTRUMENTS assessment and identification of the type and, or the measuring instruments include the following information: (

1. a)a general description of the measuring instrument; (
2. b)conceptual design and manufacturing drawings and plans of components, sub-assemblies, circuits, etc.; (
3. c)manufacturing production; procedures to ensure consistent (
4. d)if applicable, a description of the electronic devices with drawings, diagrams, flow diagrams of the logic and general software information explaining their characteristics and operations; (
5. e)descriptions and explanations necessary for the understanding of the information referred to in paragraphs (b), (
6. c)and (d), including the operation of the measuring instrument; (
7. f)a list of the harmonised standards and, or normative documents referred to in regulation, applied in full or in part, the references of which have been published in the Official Journal of the European Union; (
8. g)descriptions of the solutions adopted to meet the essential requirements where the harmonised standards and/or normative documents referred to in regulation 16 have not been applied, including a list of other relevant technical specifications applied; (
9. h)results of design calculations, examinations, etc.; (
10. i)the appropriate test results, where necessary, to demonstrate that the type and, or the measuring instruments comply with the following: (
11. i)the requirements of these regulations under declared rated operating conditions and under specified environmental disturbances; and (
12. ii)the durability specifications for gas-, water-, thermal energy-meters as well as for liquids other than water; (
13. j)the EU-type examination certificates or EU design examination certificates in respect of measuring instruments containing parts identical to those in the design.

(4)The manufacturer shall specify where seals and markings have been applied.

(5)The manufacturer shall indicate the conditions for compatibility with interfaces and sub-assemblies, where relevant. EU declaration of conformity. 19.

(1)The EU declaration of conformity shall state that the fulfilment of the essential requirements set out in Schedule I and in the relevant instrument-specific Schedules has been demonstrated.

(2)The EU declaration of conformity shall have the model structure set out in Schedule XIII, shall contain the elements specified in the relevant modules set out in Schedule II and shall be MEASURING INSTRUMENTS [ S.L.454.15 11 continuously updated. It shall be translated in at least English and, or Maltese.

(3)Where a measuring instrument is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned, including their publication references.

(4)By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the measuring instrument with the requirements laid down in these regulations.

1. The conformity of a measuring instrument with these regulations shall be indicated by the presence on it of the CE marking and the supplementary metrology marking as specified in regulation
2. Conformity marking. 21.

(1)The CE marking shall be subject to the general principles set out in regulation 30 of Regulation (EC) No 765/2008. General principles of the CE marking and of the supplementary metrology marking.

(2)The supplementary metrology marking shall consist of the capital letter ‘M’ and the last two digits of the year of its affixing, surrounded by a rectangle. The height of the rectangle shall be equal to the height of the CE marking.

(3)The general principles set out in regulation 30 of Regulation (EC) No 765/2008 shall apply, mutatis mutandis, to the supplementary metrology marking. 22.

(1)The CE marking and the supplementary metrology marking shall be affixed visibly, legibly and indelibly to the measuring instrument or to its data plate. Where that is not possible or not warranted on account of the nature of the measuring instrument, they shall be affixed to the accompanying documents and to the packaging, if any.

(2)When a measuring instrument consists of a set of devices, not being sub-assemblies, operating together, the CE marking and the supplementary metrology marking shall be affixed on the instrument’s main device.

(3)The CE marking and the supplementary metrology marking shall be affixed before the measuring instrument is placed on the market.

(4)The CE marking and the supplementary metrology marking may be affixed to the instrument during the fabrication process, if justified.

(5)The supplementary metrology marking shall immediately follow the CE marking.

(6)The CE marking and the supplementary metrology marking shall be followed by the identification number of the notified body, where that body is involved in the production control phase as set out in Schedule II.

(7)The identification number of the notified body shall be Rules and conditions for affixing the CE marking and the supplementary metrology marking. 12 [ S.L.454.15 MEASURING INSTRUMENTS affi xed b y the body itself or, under its instructions, by the manufacturer or his authorised representative.

(8)The identification number of the notified body concerned shall be indelible or self destructive upon removal.

(9)The CE marking, the supplementary metrology marking and, where applicable, the identification number of the notified body may be followed by any other mark indicating a special risk or use.

(10)The Authority shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. Notification. 23. The Authority shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under these regulations. Notifying authorities. 24.

(1)The Authority shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with the provisions of regulation 29.

(2)The assessment and monitoring referred to in regulation 21

(1)shall be carried out by the National Accreditation Board (Malta). Requirements relating to notifying authorities. 25.

(1)The Authority shall be: (

1. a)established in such a way that no conflict of interest with conformity assessment bodies occurs; (
2. b)organised and operated so as to safeguard the objectivity and impartiality of its activities; (
3. c)be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment; (
4. d)not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis; (
5. e)safeguard the confidentiality of the information it obtains; (
6. f)have a sufficient number of competent personnel at its disposal for the proper performance of its tasks. Information obligation on notifying authorities. 26. The Authority shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto. Requirements relating to notified bodies. 27.

(1)For the purposes of notification, a conformity assessment body shall meet the requirements laid down in subregulations

(2)to

(11). MEASURING INSTRUMENTS [ S.L.454.15

(2)A conformity assessment body shall be established under national law of Malta and have legal personality.

(3)A conformity assessment body shall be a third-party body independent of the organisation or the measuring instrument it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of measuring instruments which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

(4)A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the measuring instruments which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed measuring instruments that are necessary for the operations of the conformity assessment body or the use of such measuring instruments for personal purposes. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those measuring instruments, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services. The second paragraph does not, however, preclude the possibility of exchanges of technical information between the m a n u f a c t u r e r a n d t h e b od y f o r th e pu r p o s e s o f c o n f o r m i ty assessment. Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

(5)Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

(6)A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Schedule II and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility. At all times and for each 13 14 [ S.L.454.15 MEASURING INSTRUMENTS conformity assessment procedure and each kind or category of measuring instruments in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary: (

1. a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (
2. b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities; (
3. c)procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the measuring instrument technology in question and the mass or serial nature of the production process. A conformity assessment body shall have the means necessary to perform the technical and administrative tasks c o n n e c t ed w i t h t h e c o n f o r m i t y as s e s s m en t a c t i v i t i e s i n a n a p p r o p r i a t e m an n e r a n d sh al l h a v e a c c e s s t o a l l n e c es s a r y equipment or facilities.

(7)The personnel responsible for carrying out conformity assessment tasks shall have the following: (

1. a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified; (
2. b)satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; (
3. c)appropriate knowledge and understanding of the essential requirements set out in Schedule I and in the relevant instrument-specific Schedules, of the applicable harmonised standards and normative documents and of the relevant provisions of Union harmonisation legislation and of national legislation; (
4. d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

(8)The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed. The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments. MEASURING INSTRUMENTS [ S.L.454.15 15

(9)Conformity assessment bodies shall take out liability insurance unless liability is assumed by the Government of Malta in accordance with national law, or the Authority itself is directly responsible for the conformity assessment.

(10)The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Schedule II or any provision of national law giving effect to it, except in relation to the competent authorities of Malta in which its activities are carried out. Proprietary rights shall be protected.

(11)Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the c o n f o r m i t y a s s e s s m e n t t a s k s a re i n f o r m e d o f , t h e r el ev a n t standardisation activities and the activities of the notified body coordination group established under the relevant Union harmonisation legislation and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group. 28. Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in regulation 27 in so far as the applicable harmonised standards cover those requirements. Presumption of conformity of notified bodies. 29.

(1)Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in regulation 27 and shall inform the Authority accordingly. Subsidiaries of and subcontracting by notified bodies.

(2)Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

(3)Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

(4)Notified bodies shall keep at the disposal of the Authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Schedule II. 30.

(1)An accredited in-house body may be used to carry out conformity assessment activities for the undertaking of which it forms a part for the purpose of implementing the procedures set out in point 2 (Module A2) and point 5 (Module C2) of Schedule II. That body shall constitute a separate and distinct part of the undertaking and shall not participate in the design, production, s u p p l y, i n s t a l l a t i o n , u s e o r m a i n t e n a n c e o f t h e m e a s u r i n g instruments it assesses.

(2)An accredited in-house body shall meet the following requirements: Accredited inhouse bodies 16 [ S.L.454.15 MEASURING INSTRUMENTS (

1. a)it shall be accredited in accordance with Regulation (EC) No 765/2008; (
2. b)the body and its personnel shall be organisationally identifiable and have reporting methods within the undertaking of which they form a part which ensure their impartiality and demonstrate it to the relevant national accreditation body; (
3. c)neither the body nor its personnel shall be responsible for the design, manufacture, supply, installation, operation or maintenance of the measuring instruments they assess nor shall they engage in any activity that might conflict with their independence of judgment or integrity in relation to their assessment activities; (
4. d)it shall supply its services exclusively to the undertaking of which it forms a part.

(3)An accredited in-house body shall not be notified the Authority, but information concerning its accreditation shall be given by the undertaking of which it forms a part or by the National Accreditation Board (Malta) to the Authority at the request of the Authority. Application for notification. 31.

(1)A conformity assessment body established in Malta shall submit an application for notification under these regulations to the Authority.

(2)The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the measuring instrument or measuring instruments for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by National Accreditation Board (Malta) attesting that the conformity assessment body fulfils the requirements laid down in regulation 27. Notification procedure. 32.

(1)The Authority may notify only conformity assessment b od ie s w hi c h ha ve s a t is f i e d th e req u ir e m e nt s lai d do wn in regulation 27.

(2)They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.

(3)The notification shall include information on the kind(

1. s)of measuring instrument(
2. s)for which each body has been designated and, where relevant, the instrument accuracy classes, the measuring range, the measurement technology, and any other instrument characteristic limiting the scope of the notification. The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and measuring instrument or measuring instruments concerned and the relevant attestation of competence.

(4)The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an MEASURING INSTRUMENTS [ S.L.454.15 17 accreditation certificate is used.

(5)Only such a body shall be considered a notified body for the purposes of these regulations.

(6)The Authority shall notify the Commission and the other M e m b e r St a t e s o f a n y s u b s e q u e n t r e l e v a n t c h a n g e s t o t h e notification. 33.

(1)Where the Authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in regulation 27, or that it is failing to fulfil its obligations, the Authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly. Changes to notifications.

(2)In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the Authority shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the Authority. 34. The Authority shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned. Challenge of the competence of notified bodies. 35.

(1)Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Schedule II. Operational obligations of notified bodies.

(2)Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the measuring instrument technology in question and the mass or serial nature of the production process. In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the measuring instrument with these regulations.

(3)Where a notified body finds that the essential requirements set out in Schedule I and in the relevant instrument-specific Schedule or corresponding harmonised standards, normative documents or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate of conformity.

(4)Where, in the course of the monitoring of conformity following the issue of a certificate, a notified body finds that a measuring instrument no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary.

(5)Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates, as appropriate. 18 [ S.L.454.15 MEASURING INSTRUMENTS Appeal against decisions of notified bodies. 36. The Authority shall ensure that an appeal procedure against decisions of the notified bodies is available. Information obligation on notified bodies. 37.

(1)Notified bodies shall inform the Authority of the following: (

1. a)any refusal, restriction, suspension or withdrawal of a certificate; (
2. b)any circumstances affecting the scope of or conditions for notification; (
3. c)any request for information which they have received from market surveillance authorities regarding conformity assessment activities; (
4. d)on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

(2)Notified bodies shall provide the other bodies notified under these regulations carrying out similar conformity assessment activities covering the same measuring instruments with relevant information on issues relating to negative and, on request, positive conformity assessment results. Coordination of notified bodies.

1. The Authority shall ensure that the bodies notified by them participate in the work of that group or those groups, directly or by means of designated representatives. Union market surveillance and control of measuring instruments entering the Union market.
2. Regulation 16

(3)and Regulation 16 to 29 of Regulation (EC) No 765/2008 shall apply to measuring instruments. Procedure for dealing with measuring instruments presenting a risk at national level. 40.

(1)Where the Authority have sufficient reason to believe that a measuring instrument covered by these regulations presents a risk to aspects of public interest protection covered by these regulations, they shall carry out an evaluation in relation to the measuring instrument concerned covering all relevant requirements laid down in these regulations. The relevant economic operators shall cooperate as necessary with the Authority for that purpose. Where, in the course of the evaluation referred to in the first paragraph, the Authority finds that the measuring instrument d o e s n o t c o m p l y w i t h t h e r e q u i r e m en t s l a i d d o w n i n t h e s e regulations, it shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the measuring instrument into compliance with those requirements, to withdraw the measuring instrument from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe. The Authority shall inform the relevant notified body accordingly. Regulation 21 of Regulation (EC) No 765/2008 shall apply MEASURING INSTRUMENTS [ S.L.454.15 to the measures referred to in the second paragraph.

(2)Where the Authority considers that non-compliance is not restricted to Malta, it shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

(3)The economic operator shall ensure that all appropriate corrective action is taken in respect of all the measuring instruments concerned that it has made available on the market throughout the Union.

(4)Where the relevant economic operator does not take adequate corrective action within the period referred to in the second paragraph of sub-regulation

(1), the Authority shall take all appropriate provisional measures to prohibit or restrict the measuring instrument being made available on their national market, to withdraw the measuring instrument from that market or to recall it. The Authority shall inform the Commission and the other Member States, without delay, of those measures.

(5)The information referred to in the second paragraph of subregulation

(4)shall include all available details, in particular the d a t a n e c e s sa r y f o r t h e i d e n t i f i ca t i o n o f t h e n o n - c o m p l i a n t measuring instrument, the origin of the measuring instrument, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the Authority shall indicate whether the non-compliance is due to either of the following: (a) failure of the measuring instrument to meet requirements relating to aspects of public interest protection laid down in these regulations; or (b) shortcomings in the harmonised standards or normative documents referred to in regulation 18 conferring a presumption of conformity.

(6)Member States other than Malta initiating the procedure under this regulation shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the noncompliance of the measuring instrument concerned, and, in the event of disagreement with the adopted national measure, of their objections.

(7)Where, within three months of receipt of the information referred to in the second paragraph of sub-regulation

(4), no o b j e c t i o n h a s b e e n r a i s e d b y e i t h e r a M e m b e r St a t e o r t h e Commission in respect of a provisional measure taken the Authority, that measure shall be deemed justified.

(8)The Authority shall ensure that appropriate restrictive measures, such as withdrawal of the measuring instrument from the market, are taken in respect of the measuring instrument concerned, without delay. 19 20 [ S.L.454.15 MEASURING INSTRUMENTS Union safeguard procedure. 41. If the national measure is considered justified, the Authority shall take the necessary measures to ensure that the noncompliant measuring instrument is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Authority shall withdraw that measure. Compliant measuring instruments which present a risk. 42.

(1)Where, having carried out an evaluation under regulation 40

(1), the Authority finds that although a measuring instrument is in compliance with these regulations, it presents a risk to aspects of public interest protection, it shall require the relevant economic operator to take all appropriate measures to ensure that the measuring instrument concerned, when placed on the market, no longer presents that risk, to withdraw the measuring instrument from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.

(2)The economic operator shall ensure that corrective action is taken in respect of all the measuring instruments concerned that he has made available on the market throughout the Union.

(3)The Authority shall immediately inform the Commission and the other Member States that information shall include all available details, in particular the data necessary for the identification of the measuring instrument concerned, the origin and the supply chain of the measuring instrument, the nature of the risk involved and the nature and duration of the national measures taken. Formal noncompliance. 43.

(1)Without prejudice to regulation 40, where the Authority makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: (

1. a)the CE marking or the supplementary metrology marking has been affixed in violation of Regulation 30 of Regulation (EC) No 765/2008 or of regulation 22 of these regulations; (
2. b)the CE marking or the supplementary metrology marking has not been affixed; (
3. c)the identification number of the notified body, where that body is involved in the production control phase, has been affixed in violation of regulation 22 or has not been affixed; (
4. d)the EU declaration of conformity does not accompany the measuring instrument; (
5. e)the EU declaration of conformity has not been drawn up correctly; (
6. f)technical documentation is either not available or not complete; (
7. g)the information referred to in regulation 10

(6)or regulation 12

(3)is absent, false or incomplete; (h) any other administrative requirement provided for in MEASURING INSTRUMENTS [ S.L.454.15 regulation 9 or regulation 12 is not fulfilled.

(2)Where the non-compliance referred to in sub-regulation

(1)persists the Authority shall take all appropriate measures to restrict or prohibit the measuring instrument being made available on the market or ensure that it is recalled or withdrawn from the market. 44.

(1)the Authority shall not impede the making available on the market and/or the putting into use of measuring instruments covered by Regulation 2004/22/EC which are in conformity with that Regulation and which were placed on the market before 20 April 2016. Transitory provisions. Certificates issued under Regulation 2004/22/EC shall be valid under these regulations.

(2)The effects of regulation 23 of Regulation 2004/22/EC shall continue until 30th October, 2016. 45.

(1)Where reference is made to this sub-regulation, Regulation 4 of Regulation (EU) No. 182/2011 shall apply.

(2)Where reference is made to this sub-regulation, Regulation 5 of Regulation (EU) No. 182/2011 shall apply. Committee procedure. 21 22 [ S.L.454.15 MEASURING INSTRUMENTS SCHEDULE I ESSENTIAL REQUIREMENTS A measuring instrument shall provide a high level of metrological protection in order that any party affected can have confidence in the result of measurement, and shall be designed and manufactured to a high level of quality in respect of the measurement technology and security of the measurement data. The essential requirements that shall be met by measuring instruments are set out below and are supplemented, where appropriate, by specific instrument requirements in Schedules III to XII that provide more detail on certain aspects of the general requirements. The solutions adopted in the pursuit of the essential requirements shall take account of the intended use of the instrument and any foreseeable misuse thereof. Definitions: Measurand The measurand is the particular quantity subject to measurement. Influence quantity An influence quantity is a quantity that is not the measurand but that affects the result of measurement. Rated Operating Conditions The rated operating conditions are the values for the measurand and influence quantities making up the normal working conditions of an instrument. Disturbance An influence quantity having a value within the limits specified in the appropriate requirement but outside the specified rated operating conditions of the measuring instrument. An influence quantity is a disturbance if for that influence quantity the rated operating conditions are not specified. Critical change value The critical change value is the value at which the change in t he m easurem ent result is considered undesirable. Material Measure A material measure is a device intended to reproduce or supply in a permanent manner during its use one or more known values of a given quantity. Direct sales A trading transaction is direct sales if: - the measurement result serves as the basis for the price to pay; and - at least one of the parties involved in the transaction related to measurement is a consumer or any other party requiring a similar level of protection; and - Climatic environments Utility all the parties in the transaction accept the measurement result at that time and place. Climatic environments are the conditions in which measuring instruments may be used. To cope with climatic differences between the Member States, a range of temperature limits has been defined. A utility is regarded as a supplier of electricity, gas, thermal energy or water. MEASURING INSTRUMENTS [ S.L.454.15 23 ESSENTIAL REQUIREMENTS 1. Allowable Errors

(1)Under rated operating conditions and in the absence of a disturbance, the error of measurement shall not exceed the maximum permissible error (MPE) value as laid down in the appropriate instrument-specific requirements. Unless stated otherwise in the instrument-specific schedules, MPE is expressed as a bilateral value of the deviation from the true measurement value.

(2)Under rated operating conditions and in the presence of a disturbance, the performance requirement shall be as laid down in the appropriate instrument-specific requirements. Where the instrument is intended to be used in a specified permanent continuous electromagnetic field the permitted performance during the radiated electromagnetic field-amplitude modulated test shall be within MPE.

(3)The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the instrument is intended to be used, power supply and other influence quantities likely to affect its accuracy, taking account of the requirements laid down in the appropriate instrument-specific schedules. (3.1) Climatic environments The manufacturer shall specify the upper temperature limit and the lower temperature limit from any of the values in Table 1 unless otherwise specified in the Schedules III to XII, and indicate whether the instrument is designed for condensing or non-condensing humidity as well as the intended location for the instrument, i.e. open or closed. Table 1 Upper temperature limit Lower temperature limit Temperature Limits 30°C 40°C 5°C - 10°C 55°C - 25°C 70°C - 40°C (3.2). (

1. a)Mechanical environments are classified into classes M1 to M3 as described below. M1 This class applies to instruments used in locations with vibration and shocks of low significance, e.g. for instruments fastened to light supporting structures subject to negligible vibrations and shocks transmitted from local blasting or pile-driving activities, slamming doors, etc. This class applies to instruments used in locations with significant or high levels of vibration and shock, e.g. transmitted from machines and passing vehicles in the vicinity or adjacent to heavy machines, conveyor belts, etc. This class applies to instruments used in locations where the level of vibration and shock is high and very high, e.g. for instruments mounted directly on machines, conveyor belts, etc. M2 M3 (
2. b)The following influence quantities shall be considered in relation with mechanical environments: - Vibration; - Mechanical shock. 24 [ S.L.454.15 MEASURING INSTRUMENTS (3.3). (
3. a)Electromagnetic environments are classified into classes E1, E2 or E3 as described below, unless otherwise laid down in the appropriate instrument-specific schedules. E1 This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in residential, commercial and light industrial buildings. This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in other industrial buildings. This class applies to instruments supplied by the battery of a vehicle. Such instruments shall comply with the requirements of E2 and the following additional requirements: E2 E3 - voltage reductions caused by energising the starter-motor circuits of internal combustion engines, - load dump transients occurring in the event of a discharged battery being disconnected while the engine is running. (
4. b)The following influence quantities shall be considered in relation with electromagnetic environments: - voltage interruptions; - short voltage reductions; - voltage transients on supply lines and/or signal lines; - electrostatic discharges - radio frequency electromagnetic fields; - conducted radio frequency electromagnetic fields on supply lines and/or signal lines; - surges on supply lines and/or signal lines. (3.4) Other influence quantities to be considered, where appropriate, are: - voltage variation; - mains frequency variation; - power frequency magnetic fields; - any other quantity likely to influence in a significant way the accuracy of the instrument.

(4)When carrying out the tests as envisaged in these regulations, the following points shall apply: (4.1). Basic rules for testing and the determination of errors Essential requirements specified in points 1.1 and 1.2 shall be verified for each relevant influence quantity. Unless otherwise specified in the appropriate instrument-specific schedules, these essential requirements apply when each influence quantity is applied and its effect evaluated separately, all other influence quantities being kept relatively constant at their reference value. Metrological tests shall be carried out during or after the application of the influence quantity, whichever condition corresponds to the normal operational status of the instrument when that influence quantity is likely to occur. (4.2) Ambient humidity MEASURING INSTRUMENTS [ S.L.454.15 25 (

1. a)According to the climatic operating environment in which the instrument is intended to be used either the damp heat-steady state (noncondensing) or damp heat cyclic (condensing) test may be appropriate. (
2. b)The damp heat cyclic test is appropriate where condensation is important or when penetration of vapour will be accelerated by the effect of breathing. In conditions where non-condensing humidity is a factor the damp- heat steady state is appropriate. 2. Reproducibility The application of the same measurand in a different location or by a different user, all other conditions being the same, shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE. 3. Repeatability The application of the same measurand under the same conditions of measurement shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE. 4. Discrimination and Sensitivity A measuring instrument shall be sufficiently sensitive and the discrimination threshold shall be sufficiently low for the intended measurement task. 5. Durability A measuring instrument shall be designed to maintain an adequate stability of i t s m e t r o l og i c a l c h a r a c t e r i s t i c s o v e r a p e r i o d o f t im e es t i ma t e d b y th e manufacturer, provided that it is properly installed, maintained and used according to the manufacturer’s instruction when in the environmental conditions for which it is intended. 6. Reliability A measuring instrument shall be designed to reduce as far as possible the effect of a defect that would lead to an inaccurate measurement result, unless the presence of such a defect is obvious. 7. Suitability

(1)A measuring instrument shall have no feature likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal.

(2)A measuring instrument shall be suitable for its intended use taking account of the practical working conditions and shall not require unreasonable demands of the user in order to obtain a correct measurement result.

(3)The errors of a utility measuring instrument at flows or currents outside the controlled range shall not be unduly biased.

(4)Where a measuring instrument is designed for the measurement of values of the measurand that are constant over time, the measuring instrument shall be insensitive to small fluctuations of the value of the measurand, or shall take appropriate action.

(5)A measuring instrument shall be robust and its materials of construction shall be suitable for the conditions in which it is intended to be used.

(6)A measuring instrument shall be designed so as to allow the control of the measuring tasks after the instrument has been placed on the market and put into use. 26 [ S.L.454.15 MEASURING INSTRUMENTS If necessary, special equipment or software for this control shall be part of the instrument. The test procedure shall be described in the operation manual. When a measuring instrument has associated software which provides other functions besides the measuring function, the software that is critical for the metrological characteristics shall be identifiable and shall not be inadmissibly influenced by the associated software. 8. Protection against corruption

(1)The metrological characteristics of a measuring instrument shall not be influenced in any inadmissible way by the connection to it of another device, by any feature of the connected device itself or by any remote device that communicates with the measuring instrument.

(2)A hardware component that is critical for metrological characteristics shall be designed so that it can be secured. Security measures foreseen shall provide for evidence of an intervention.

(3)Software that is critical for metrological characteristics shall be identified as such and shall be secured. Software identification shall be easily provided by the measuring instrument. Evidence of an intervention shall be available for a reasonable period of time.

(4)Measurement data, software that is critical for measurement characteristics and metrologically important parameters stored or transmitted shall be adequately protected against accidental or intentional corruption.

(5)For utility measuring instruments the display of the total quantity supplied or the displays from which the total quantity supplied can be derived, whole or partial reference to which is the basis for payment, shall not be able to be reset during use. 9. Information to be borne by and to accompany the instrument

(1)A measuring instrument shall bear the following inscriptions: (

1. a)manufacturer’s name, registered trade name or registered trade mark; (
2. b)information in respect of its accuracy; and, where applicable; (
3. c)information in respect of the conditions of use; (
4. d)measuring capacity; (
5. e)measuring range; (
6. f)identity marking; (
7. g)number of the EU-type examination certificate or the EU design examination certificate; (
8. h)information whether or not additional devices providing metrological results comply with the provisions of these regulations on legal metrological control.

(2)An instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its packaging, if any, and the accompanying documents required by the provisions of these regulations suitably marked.

(3)The instrument shall be accompanied by information on its operation, unless the simplicity of the measuring instrument makes this unnecessary. Information shall [ S.L.454.15 MEASURING INSTRUMENTS 27 be easily understandable and shall include where relevant: (

1. a)rated operating conditions; (
2. b)mechanical and electromagnetic environment classes; (
3. c)the upper and lower temperature limit, whether condensation is possible or not, open or closed location; (
4. d)instructions for adjustments; installation, maintenance, repairs, permissible (
5. e)instructions for correct operation and any special conditions of use; (
6. f)conditions for compatibility with interfaces, sub-assemblies or measuring instruments.

(4)Groups of identical measuring instruments used in the same location or used for utility measurements do not necessarily require individual instruction manuals.

(5)Unless specified otherwise in an instrument-specific schedule, the scale interval for a measured value shall be in the form 1 × 10n, 2 × 10n, or 5 × 10n, where n is any integer or zero. The unit of measurement or its symbol shall be shown close to the numerical value.

(6)A material measure shall be marked with a nominal value or a scale, accompanied by the unit of measurement used.

(7)The units of measurement used and their symbols shall be in accordance with the provisions of Union legislation on units of measurement and their symbols.

(8)All marks and inscriptions required under any requirement shall be clear, non-erasable, unambiguous and non- transferable. 10. Indication of result

(1)Indication of the result shall be by means of a display or hard copy.

(2)The indication of any result shall be clear and unambiguous and accompanied by such marks and inscriptions necessary to inform the user of the significance of the result. Easy reading of the presented result shall be permitted under normal conditions of use. Additional indications may be shown provided they cannot be confused with the metrologically controlled indications.

(3)In the case of hard copy the print or record shall also be easily legible and non-erasable.

(4)A measuring instrument for direct sales trading transactions shall be designed to present the measurement result to both parties in the transaction when installed as intended. When critical in case of direct sales, any ticket provided to the consumer by an ancillary device not complying with the appropriate requirements of these regulations shall bear appropriate restrictive information.

(5)Whether or not a measuring instrument intended for utility measurement purposes can be remotely read it shall in any case be fitted with a metrological controlled display accessible without tools to the consumer. The reading of this display is the measurement result that serves as the basis for the price to pay. 11. Further processing of data to conclude the trading transaction

(1)A measuring instrument other than a utility measuring instrument shall record by a durable means the measurement result accompanied by information to identify the particular transaction, when: (

1. a)the measurement is non-repeatable; and 28 [ S.L.454.15 MEASURING INSTRUMENTS (
2. b)the measuring instrument is normally intended for use in the absence of one of the trading parties.

(2)Additionally, a durable proof of the measurement result and the information to identify the transaction shall be available on request at the time the measurement is concluded.

1. Conformity evaluation A measuring instrument shall be designed so as to allow ready evaluation of its conformity with the appropriate requirements of these regulations. SCHEDULE II MODULE A: INTERNAL PRODUCTION CONTROL
2. ‘Internal production control’ is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of these regulations that apply to them.
3. Technical documentation The manufacturer shall establish the technical documentation as described in regulation
4. The documentation shall make it possible to assess the instrument’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requi rements and cover, as far as r el ev an t for the assessment, the desig n, manufacture and operation of the instrument.
5. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured instruments with the technical documentation referred to in point 2 and with the requirements of these regulations that apply to them.
6. Conformity marking and EU declaration of conformity

(1)The manufacturer shall affix the CE marking and the supplementary metrology marking set out in these regulations to each individual measuring instrument that satisfies the applicable requirements of these regulations.

(2)The manufacturer shall draw up a written EU declaration of conformity for an instrument model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the measuring instrument has been placed on the market. The EU declaration of conformity shall identify the instrument for which it was drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

1. Authorised representative The manufacturer’s obligations set out in point 4 may be fulfilled by his MEASURING INSTRUMENTS [ S.L.454.15 29 authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. MODULE A2: INTERNAL PRODUCTION CONTROL SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS PLUS Internal production control plus supervised instrument checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4, and 5, and ensures and declares on his s o l e r e s p o n s i b i l i t y t h a t t h e m e a s u r i n g i n s t r u m e n t s c o n c e r n e d s at i s f y t h e requirements of these regulations that apply to them.
2. Technical documentation The manufacturer shall establish the technical documentation as described in regulation
3. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument.
4. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured instruments with the technical documentation referred to in point 2 and with the requirements of these regulations that apply to them.
5. Instrument checks At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer, shall carry out instrument checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks of the instrument, taking into account, inter alia, the technological complexity of the instruments and the quantity of production. An adequate sample of the final measuring instruments, taken on site by the body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standard, and/or normative document, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify the conformity of the instruments with the relevant requirements of these regulations. In the absence of a relevant harmonised standard or normative document, the accredited in-house body or notified body concerned shall decide on the appropriate tests to be carried out. In those cases where a relevant number of instruments in the sample do not conform to an acceptable quality level, the accredited in-house body or notified body shall take appropriate measures. Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
6. Conformity marking and EU declaration of conformity

(1)The manufacturer shall affix the CE marking and the supplementary metrology marking set out in these regulations to each individual instrument that satisfies the applicable requirements of these regulations.

(2)The manufacturer shall draw up a written EU declaration of conformity for an instrument model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the instrument has been placed 30 [ S.L.454.15 MEASURING INSTRUMENTS on the market. The EU declaration of conformity shall identify the instrument for which it was drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. 6. Authorised representative The manufacturer’s obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility provided that they are specified in the mandate. MODULE B: EU- TYPE EXAMINATION 1. ‘EU-type examination’ is the part of a conformity assessment procedure in which a notified body examines the technical design of an instrument and verifies and attests that the technical design of the instrument meets the requirements of these regulations that apply to it. 2. EU-type examination may be carried out in either of the following manners: (

1. a)examination of a specimen, representative of the production envisaged, of the complete measuring instrument (production type), (
2. b)assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the instrument (combination of production type and design type); (
3. c)assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type). The notified body decides on the appropriate manner and the specimens required. 3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include: (
4. a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (
5. b)a written declaration that the same application has not been lodged with any other notified body; (
6. c)the technical documentation as described in regulation 16. The technical documentation shall make it possible to assess the instrument’s conformity with the applicable requirements of these regulations and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. The application shall in addition contain, wherever applicable; (
7. d)the specimens, representative of the production envisaged. The notified MEASURING INSTRUMENTS [ S.L.454.15 31 body may request further specimens if needed for carrying out the test programme; (
8. e)the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards, and/or normative documents have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility. 4. The notified body shall: For the instrument:

(1)examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the instrument; For the specimen(s):

(2)verify that the specimen(s) have been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/ or normative documents, as well as the elements which have been designed in accordance with other relevant technical specifications;

(3)carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and normative documents, these have been applied correctly;

(4)carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards, and/or normative docum en ts have not b een applied, the solu tions ado pted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of these regulations

(5)agree with the manufacturer on the location where the examinations and tests will be carried out. For the other parts of the measuring instrument:

(6)examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the other parts of the measuring instrument.

1. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis, the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
2. Where the type meets the requirements of these regulations, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The EU-type examination certificate may have one or more schedules attached. The EU-type examination certificate and its schedules shall contain all relevant information to allow the conformity of manufactured measuring instruments with the examined type to be evaluated and to allow for in-service control. In particular, to allow the conformity of manufactured instruments to be evaluated with 32 [ S.L.454.15 MEASURING INSTRUMENTS the examined type regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, content shall include: - the metrological characteristics of the type of instrument - measures required for ensuring the integrity of the instruments (sealing, identification of software, etc.); - information on other elements necessary for the identification of the instruments and to check their visual external conformity to type; - if appropriate, any specific information necessary to verify the characteristics of manufactured instruments; - in the case of a sub-assembly, all necessary information to ensure the compatibility with other sub-assemblies or measuring instruments. The EU-type examination certificate shall have a validity of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each. Where the type does not satisfy the applicable requirements of these regulations, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
3. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these regulations, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.
4. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the instrument with the essential requirements of these regulations or the conditions for validity of that certificate Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.
5. Each notified body shall inform the Authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its schedules and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of that certificate.
6. The manufacturer shall keep a copy of the EU-type examination certificate, its schedules and additions together with the technical documentation at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
7. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 8 and 10, provided that they are specified in the mandate. MEASURING INSTRUMENTS [ S.L.454.15 33 MODULE C: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
8. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the measuring instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of these regulations that apply to them.
9. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured measuring instruments with the approved type described in the EU-type examination certificate and with the requirements of these regulations that apply to them.
10. Conformity marking and EU declaration of conformity

(1)The manufacturer shall affix the CE marking and the supplementary metrology marking set out in these regulations to each individual instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of these regulations.

(2)The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it was drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

1. Authorised representative The manufacturer’s obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS
2. Conformity to type based on internal production control plus supervised instrument checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the measuring instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of these regulations that apply to them.
3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured measuring instruments with the type described in the EU-type examination certificate and with the requirements of these regulations that apply to them.
4. Instrument checks 34 [ S.L.454.15 MEASURING INSTRUMENTS At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer, shall carry out instrument checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks on the instrument, taking into account, inter alia, the technological complexity of the measuring instruments and the quantity of production. An adequate sample of the final measuring instrument, taken on site by the accredited in-house body or by the notified body before the placing on the market, shall be examined and appropriate tests, as identified by the relevant parts of the harmonised standards, and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify the conformity of the instrument with the type described in the EU-type examination certificate and with the relevant requirements of these regulations. Where a sample does not conform to an acceptable quality level, the accredited in-house body or notified body shall take appropriate measures. The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the instrument performs within acceptable limits, with a view to ensuring conformity of the instrument. Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
5. Conformity marking and EU declaration of conformity

(1)The manufacturer shall affix the CE marking, and the supplementary metrology marking set out in these regulations to each individual measuring instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of these regulations.

(2)The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

1. Authorised representative The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. MODULE D: CONFORMITY TO TYPE ASSURANCE OF THE PRODUCTION PROCESS BASED ON QUALITY
2. Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the measuring instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of these regulations that apply to them.
3. Manufacturing MEASURING INSTRUMENTS [ S.L.454.15 35 The manufacturer shall operate an approved quality system for production, final product inspection and testing of the measuring instruments concerned as specified in point 3 and shall be subject to surveillance as specified in point
5. Quality system

(1)The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the measuring instruments concerned. The application shall include: (

1. a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well, (
2. b)a written declaration that the same application has not been lodged with any other notified body, (
3. c)all relevant information for the instrument category envisaged; (
4. d)the documentation concerning the quality system; (
5. e)the technical documentation of the approved type and a copy of the EUtype examination certificate.

(2)The quality system shall ensure that the measuring instruments are in conformity with the type described in the EU- type examination certificate and comply with the requirements of these regulations that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (

1. a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (
2. b)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (
3. c)the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out; (
4. d)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned; (
5. e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

(3)The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of these regulations. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in 36 [ S.L.454.15 MEASURING INSTRUMENTS point (e) of point 3.1, to verify the manufacturer’s ability to identify the relevant requirements of these regulations and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

(4)The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(5)The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 4. Surveillance under the responsibility of the notified body

(1)The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

(2)The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (

1. a)the quality system documentation; (
2. b)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

(3)The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

(4)In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. 5. Conformity marking and EU declaration of conformity

(1)The manufacturer shall affix the CE marking and the supplementary metrology marking set out in these regulations, and, under the responsibility of the notified body referred to in point 3.1, the latter ’s identification number to each individual measuring instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of these regulations.

(2)The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather MEASURING INSTRUMENTS [ S.L.454.15 37 than individual instruments in those cases where a large number of instruments are delivered to a single user. 6. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities: (

1. a)the documentation referred to in point 3.1, (
2. b)the information relating to the change referred to in point 3.5, as approved; (
3. c)the decisions and reports from the notified body referred to in points 3.5, 4.3 and 4.4. 7. Each notified body shall inform the Authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Authority the list of quality system approvals refused, suspended or otherwise restricted. 8. Authorised representative The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION PROCESS 1. Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of these regulations that apply to them. 2. Technical documentation The manufacturer shall establish the technical documentation as described in regulation 18. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. 3. The manufacturer shall keep the technical documentation at the disposal of the national authorities for 10 years after the instrument has been placed on the market. 4. Manufacturing The manufacturer shall operate an approved quality system for production, final product inspection and testing of the measuring instruments concerned as specified in point 5 and shall be subject to surveillance as specified in point 6. 5. Quality system

(1)The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the measuring instruments concerned. The application shall include: (

1. a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (
2. b)a written declaration that the same application has not been lodged with any other notified body; 38 [ S.L.454.15 MEASURING INSTRUMENTS (
3. c)all relevant information for the instrument category envisaged; (
4. d)the documentation concerning the quality system; (
5. e)the technical documentation referred to in point 2.

(2)The quality system shall ensure compliance of the measuring instruments with the requirements of these regulations that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (

1. a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (
2. b)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (
3. c)the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out; (
4. d)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned; (
5. e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

(3)The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of these regulations. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer ’s ability to identify the relevant requirements of these regulations and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

(4)The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(5)The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 5.2 or whether are assessment is necessary. MEASURING INSTRUMENTS [ S.L.454.15 39 It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 6. Surveillance under the responsibility of the notified body

(1)The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

(2)The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (

1. a)the quality system documentation; (
2. b)the technical documentation referred to in point 2; (
3. c)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

(3)The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

(4)In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. 7. Conformity marking and EU declaration of conformity

(1)The manufacturer shall affix the CE marking, the supplementary metrology marking set out in these regulations, and, under the responsibility of the notified body referred to in point 5.1, the latter’s identification number to each individual measuring instrument that satisfies the applicable requirements of these regulations.

(2)The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. 8. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities: (

1. a)the documentation referred to in point 5.1; (
2. b)the information relating to the change referred to in point 5.5, as approved; (
3. c)the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4. 9. Each notified body shall inform the Authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Authority the list of quality system approvals refused, suspended or otherwise 40 [ S.L.454.15 MEASURING INSTRUMENTS restricted. 10. Authorised representative The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. MODULE E: CONFORMITY TO TYPE BASED ON INSTRUMENT QUALITY ASSURANCE 1. Conformity to type based on instrument quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the measuring instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of these regulations that apply to them. 2. Manufacturing The manufacturer shall operate an approved quality system for final product inspection and testing of the measuring instruments concerned as specified in point 3 and shall be subject to surveillance, as specified in point 4. 3. Quality system

(1)The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the measuring instruments concerned. The application shall include: (

1. a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (
2. b)a written declaration that the same application has not been lodged with any other notified body; (
3. c)all relevant information for the instrument category envisaged; (
4. d)the documentation concerning the quality system; (
5. e)the technical documentation of the approved type and a copy of the EUtype examination certificate.

(2)The quality system shall ensure compliance of the measuring instruments with the type described in the EU-type examination certificate and with the applicable requirements of these regulations. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (

1. a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (
2. b)the examinations and tests that will be carried out after manufacture; (
3. c)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned; (
4. d)the means of monitoring the effective operation of the quality system.

(3)The notified body shall assess the quality system to determine whether it MEASURING INSTRUMENTS [ S.L.454.15 41 satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of these regulations. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point (e) of point 3.1, in order to verify the manufacturer’s ability to identify the re le va nt r e q u ir e m e nt s of th e s e r e g u la ti on s an d t o c a r r y o u t th e n eces sary examinations with a view to ensuring compliance of the instrument with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of audit and the reasoned assessment decision.

(4)The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(5)The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 4. Surveillance under the responsibility of the notified body

(1)The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

(2)The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (

1. a)the quality system documentation; (
2. b)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

(3)The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

(4)In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. 5. Conformity marking and EU declaration of conformity

(1)The manufacturer shall affix the CE marking, the supplementary metrology marking set out in these regulations, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual 42 [ S.L.454.15 MEASURING INSTRUMENTS instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of these regulations.

(2)The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments are delivered to a single user. 6. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities: (

1. a)the documentation referred to in point 3.1; (
2. b)the information relating to the change referred to in point 3.5, as approved; (
3. c)the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. 7. Each notified body shall inform the Authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Authority the list of quality system approvals refused, suspended or otherwise restricted. 8. Authorised representative The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. MODULE E1: QUALITY ASSURANCE OF FINAL INSTRUMENT INSPECTION AND TESTING 1. Quality assurance of final instrument inspection and testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of these regulations that apply to them. 2. Technical documentation The manufacturer shall establish the technical documentation as described in regulation 18. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. 3. The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the instrument has been placed on the market. 4. Manufacturing The manufacturer shall operate an approved quality system for final product inspection and testing of the measuring instruments concerned as specified in point 5 MEASURING INSTRUMENTS [ S.L.454.15 43 and shall be subject to surveillance as specified in point 6. 5. Quality system 5

(1)The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the measuring instruments concerned. The application shall include: (

1. a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (
2. b)a written declaration that the same application has not been lodged with any other notified body; (
3. c)all relevant information for the instrument category envisaged; (
4. d)the documentation concerning the quality system; (
5. e)the technical documentation referred to in point 2.

(2)The quality system shall ensure compliance of the measuring instruments with the requirements of these regulations that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality sy