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S.I. No. 110/2009 - European Communities (Medical Devices) (Amendment) Regulations 2009

S.I. No. 110/2009 - European Communities (Medical Devices) (Amendment) Regulations 2009 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach Eng

Article 17

of Directive 93/42/EEC as amended and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer. 3. Quality system 3.1. The manufacturer must lodge an application for assessment of his or her quality system with a notified body. The application must include: — the name and address of the manufacturer and any additional manufacturing site covered by the quality system, — all the relevant information on the product or product category covered by the procedure, — a written declaration that no application has been lodged with any other notified body for the same product-related quality system, — the documentation on the quality system, — an undertaking by the manufacturer to fulfil the obligations imposed by the quality system approved, — an undertaking by the manufacturer to keep the approved quality system adequate and efficacious, — an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Schedule 10 and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them: (

  1. i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his or her state of health; (
  2. ii)any technical or medical reason connected with the characteristics or performance of a device leading for the reasons referred to in subparagraph (
  3. i)to systematic recall of devices of the same type by the manufacturer. 3.2. Application of the quality system must ensure that the products conform to the provisions of Directive 93/42/EEC as amended which apply to them at every stage, from design to final inspection. All the elements, requirements and provisions adopted by the manufacturer for his or her quality system must be documented in a systematic and orderly manner in the form of written policies and procedures such as quality programmes, quality plans, quality manuals and quality records. It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c). It shall include in particular an adequate description of: (
  4. a)the manufacturer’s quality objectives; (
  5. b)the organization of the business and in particular: — the organizational structures, the responsibilities of the managerial staff and their organizational authority where quality of design and manufacture of the products is concerned, — the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of design and of product, including control of products which fail to conform, — where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party; (
  6. c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular: — a general description of the product, including any variants planned, and its intended use(s), — the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 of Directive 93/42/EEC as amended are not applied in full, — the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed, — if the device is to be connected to other device(
  7. s)in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(
  8. s)having the characteristics specified by the manufacturer, — a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Schedule 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, — a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC, — the solutions adopted as referred to in Schedule 1, Chapter I, Section 2, — the pre-clinical evaluation, — the clinical evaluation referred to in Schedule 10, — the draft label and, where appropriate, instructions for use. (
  9. d)the inspection and quality assurance techniques at the manufacturing stage and in particular: — the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents, — the product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture; (
  10. e)the appropriate tests and trials which will be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible to trace back the calibration of the test equipment adequately. 3.3. The notified body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant harmonized standards conform to these requirements. The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product(
  11. s)concerned, an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes. The decision is notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment. 3.4. The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment. 4. Examination of the design of the product 4.1. In addition to the obligations imposed by Section 3, the manufacturer must lodge with the notified body an application for examination of the design dossier relating to the product which he plans to manufacture and which falls into the category referred to in Section 3.1. 4.2. The application must describe the design, manufacture and performances of the product in question. It must include the documents needed to assess whether the product conforms to the requirements of Directive 93/42/EEC as amended, as referred to in Section 3.2(c). 4.3. The notified body must examine the application and, if the product conforms to the relevant provisions of Directive 93/42/EEC as amended, issue the application with an EC design-examination certificate. The notified body may require the application to be completed by further tests or proof to allow assessment of conformity with the requirements of the Directive. The certificate must contain the conclusions of the examination, the conditions of validity, the data needed for identification of the approved design, where appropriate, a description of the intended purpose of the product. In the case of devices referred to in Schedule 1, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned. In the case of devices referred to in Schedule 1, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA. In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive. 4.4. Changes to the approved design must receive further approval from the notified body which issued the EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product. The applicant shall inform the notified body which issued the EC design-examination certificate of any such changes made to the approved design. This additional approval must take the form of a supplement to the EC design examination certificate. 5. Surveillance 5.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system. 5.2. The manufacturer must authorize the notified body to carry out all the necessary inspections and supply it with all relevant information, in particular: — the documentation on the quality system, — the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Schedule 1, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post- market clinical follow-up, if applicable, etc., — the data stipulated in the part of the quality system relating to manufacture, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc. 5.3. The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the approved quality system and must supply the manufacturer with an assessment report. 5.4. In addition, the notified body may pay unannounced visits to the manufacturer. At the time of such visits, the notified body may, where necessary, carry out or ask for tests in order to check that the quality system is working properly. It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. 6. Administrative provisions 6.1. The manufacturer or his or her authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities: — the declaration of conformity, — the documentation referred to in the fourth indent of Section 3.1and in particular the documentation, data and records referred to in the second paragraph of Section 3.2, — the changes referred to in Section 3.4, — the documentation referred to in Section 4.2, and — the decisions and reports from the notified body as referred to in Sections 3.3, 4.3, 4.4, 5.3 and 5.4. 7. Application to devices in Classes IIa and IIb. 7.1. In line with Article 11

(2)and
(3)of Directive 93/42/EEC as amended, this Schedule may apply to products in Classes IIa and IIb. Section 4, however, does not apply. 7.2. For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(
  1. c)for at least one representative sample for each device subcategory for compliance with the provisions of Directive 93/42/EEC as amended 7.3. For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(
  2. c)for at least one representative sample for each generic device group for compliance with the provisions of Directive 93/42/EEC as amended 7.4. In choosing representative sample(
  3. s)the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(
  4. s)taken. 7.5. Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5. 8. Application to the devices referred to Article 1
(4a)of Directive 93/42/EEC as amended.Upon completing the manufacture of each batch of devices referred to in Article 1
(4a)of Directive 93/42/EEC as amended, the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114
(2)of Directive 2001/83/EC SCHEDULE 3 EC TYPE-EXAMINATION 1. EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative sample of the production covered fulfils the relevant provisions of Directive 93/42/EEC as amended. 2. The application includes: — the name and address of the manufacturer and the name and address of the authorized representative if the application is lodged by the representative, — the documentation described in Section 3 needed to assess the conformity of the representative sample of the production in question, hereinafter referred to as the ‘type’, with the requirements of Directive 93/42/EEC as amended. The applicant must make a ‘type’ available to the notified body. The notified body may request other samples as necessary, — a written declaration that no application has been lodged with any other notified body for the same type. 3. The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular: — a general description of the type, including any variants planned, and its intended use(s), — design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc., — the descriptions and explanations necessary to understand the above mentioned drawings and diagrams and the operation of the product, — a list of the standards referred to in Article 5 of Directive 93/42/EEC as amended, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 of Directive 93/42/EEC as amended have not been applied in full, — the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out, — a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Schedule 1, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device, — a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, — the solutions adopted as referred to in Schedule 1, Chapter I, Section 2, — the pre-clinical evaluation, — the clinical evaluation referred to in Schedule 10, — the draft label and, where appropriate, instructions for use. 4. The notified body must: 4.1. examine and assess the documentation and verify that the type has been manufactured in conformity with that documentation; it must also record the items designed in conformity with the applicable provisions of the standards referred to in Article 5 of Directive 93/42/EEC as amended, as well as the items not designed on the basis of the relevant provisions of the abovementioned standards; 4.2. carry out or arrange for the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer meet the essential requirements of Directive 93/42/EEC as amended if the standards referred to in Article 5 of Directive 93/42/EEC as amended have not been applied; if the device is to be connected to other device(
  1. s)in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(
  2. s)having the characteristics specified by the manufacturer; 4.3. carry out or arrange for the appropriate inspections and the tests necessary to verify whether, if the manufacturer has chosen to apply the relevant standards, these have actually been applied; 4.4. agree with the applicant on the place where the necessary inspections and tests will be caried out. 5. If the type conforms to the provisions of Directive 93/42/EEC as amended, the notified body issues the applicant with an EC type-examination certificate. The certificate must contain the name and address of the manufacturer, the conclusions of the inspection, the conditions of validity and the data needed for identification of the type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept by the notified body. In the case of devices referred to in Schedule 1, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation.The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned. In the case of devices referred to in Schedule 1, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA. In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive. 6. The applicant must inform the notified body which issued the EC type examination certificate of any significant change made to the approved product. Changes to the approved product must receive further approval from the notified body which issued the EC type-examination certificate wherever the changes may affect conformity with the essential requirements or with the conditions prescribed for use of the product. This new approval must, where appropriate, take the form of a supplement to the initial EC type examination certificate. 7. Administrative provisions 7.2. Other notified bodies may obtain a copy of the EC type-examination certificates and/or the supplements thereto. The Annexes to the certificates must be made available to other notified bodies on reasoned application, after the manufacturer has been informed. 7.3. The manufacturer or his or her authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured. SCHEDULE 4 EC VERIFICATION 1. EC verification is the procedure whereby the manufacturer or his or her authorized representative ensures and declares that the products which have been subject to the procedure set out in Section 4 conform to the type described in the EC type-examination certificate and meet the requirements of Directive 93/42/EEC which apply to them. 2. The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which conform to the type described in the EC type-examination certificate and to the requirements of the Directive which apply to them. Before the start of manufacture, the manufacturer must prepare documents defining the manufacturing process, in particular as regards sterilization where necessary, together with all the routine, pre-established provisions to be implemented to ensure homogeneous production and, where appropriate, conformity of the products with the type described in the EC type-examination certificate and with the requirements of Directive 93/42/EEC as amended which apply to them. The manufacturer must affix

Article 17of Directive 93/42/EEC as amended and draw up a declaration of conformity.

In addition, for products placed on the market in sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer must apply the provisions of Schedule 5, Sections 3 and 4. 3. The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Schedule 10, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them: (

  1. i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his or her state of health; (
  2. ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (
  3. i)leading to systematic recall of devices of the same type by the manufacturer. 4. The notified body must carry out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of the Directive either by examining and testing every product as specified in Section 5 or by examining and testing products on a statistical basis as specified in Section 6, as the manufacturer decides. The aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility. 5. Verification by examination and testing of every product 5.1. Every product is examined individually and the appropriate tests defined in the relevant standard(
  4. s)referred to in Article 5 of Directive 93/42/EEC as amended or equivalent tests must be carried out in order to verify, where appropriate, the conformity of the products with the EC type described in the type-examination certificate and with the requirements of the Directive which apply to them. 5.2. The notified body must affix, or have affixed its identification number to each approved product and must draw up a written certificate of conformity relating to the tests carried out. 6. Statistical verification 6.1. The manufacturer must present the manufactured products in the form of homogeneous batches. 6.2. A random sample is taken from each batch. The products which make up the sample are examined individually and the appropriate tests defined in the relevant standard(
  5. s)referred to in Article 5 of Directive 93/42/EEC as amended or equivalent tests must be carried out to verify, where appropriate, the conformity of the products with the type described in the EC type-examination certificate and with the requirements of the Directive which apply to them in order to determine whether to accept or reject the batch. 6.3. Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5 of Directive 93/42/EEC as amended, taking account of the specific nature of the product categories in question. 6.4. If the batch is accepted, the notified body affixes or has affixed its identification number to each product and draws up a written certificate of conformity relating to the tests carried out. All products in the batch may be put on the market except any in the sample which failed to conform. If a batch is rejected, the competent notified body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the notified body may suspend the statistical verification. The manufacturer may, on the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process. 7. Administrative provisions The manufacturer or his or her authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities: — the declaration of conformity, — the documentation referred to in Section 2, — the certificates referred to in Sections 5.2 and 6.4, — where appropriate, the type-examination certificate referred to in Schedule 3. 8. Application to devices in Class IIa In line with Article 11

(2)of Directive 93/42/EEC as amended, this Schedule may apply to products in Class IIa, subject to the following: 8.
  1. in derogation from Sections 1 and 2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Schedule 7 and meet the requirements of Directive 93/42/EEC as amended which apply to them; 8.
  2. in derogation from Sections 1, 2, 5 and 6, the verifications conducted by the notified body are intended to confirm the conformity of the products in Class IIa with the technical documentation referred to in Section 3 of Schedule
  4. Application to devices referred to in Article 1
(4a)of Directive 93/42/EEC as amended. In the case of section 5, upon completing the manufacture of each batch of devices referred to in Article 1
(4a)of Directive 93/42/EEC as amended, and in the case of verification under section 6, the manufacturer shall inform the notified body of the release of this batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114
(2)of Directive 2001/83/EC SCHEDULE 5 EC DECLARATION OF CONFORMITY (Production quality assurance)
  1. The manufacturer must ensure application of the quality system approved for the manufacture of the products concerned and carry out the final inspection, as specified in Section 3, and is subject to the Community surveillance referred to in Section
  3. The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of Directive 93/42/EEC as amended which apply to them. The manufacturer must affix

Article 17

of Directive 93/42/EEC as amended and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer. 3. Quality system 3.1. The manufacturer must lodge an application for assessment of his or her quality system with a notified body. The application must include: — the name and address of the manufacturer, — all the relevant information on the product or product category covered by the procedure, — a written declaration that no application has been lodged with any other notified body for the same products, — the documentation on the quality system, — an undertaking to fulfil the obligations imposed by the quality system is approved, — an undertaking to maintain the practicability and effectiveness of the approved quality system, — where appropriate, the technical documentation on the types approved and a copy of the EC type-examination certificates, — an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post- production phase, including the provisions referred to in Schedule 10, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them: (

  1. i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his or her state of health; (
  2. ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (
  3. i)above leading to a systematic recall of devices of the same type by the manufacturer. 3.2. Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate. All the elements, requirements and provisions adopted by the manufacturer for his quality system must be documented in a systematic and orderly manner in the form of written policy statements and procedures. This quality system documentation must permit uniform interpretation of the quality policy and procedures such as quality programmes, plans, manuals and records. It must include in particular an adequate description of: (
  4. a)the manufacturer’s quality objectives; (
  5. b)the organization of the business and in particular: — the organizational structures, the responsibilities of the managerial staff and their organizational authority where manufacture of the products is concerned, — the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of product, including control of products which fail to conform, — where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party; (
  6. c)the inspection and quality assurance techniques at the manufacturing stage and in particular: — the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents, — the product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture; (
  7. d)the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible adequately to trace back the calibration of the test equipment. 3.3. The notified body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant harmonized standards conform to these requirements. The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers to inspect the manufacturing processes. The decision must be notified to the manufacturer after the final inspection and contain the conclusions of the inspection and a reasoned assessment. 3.4. The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system. The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. After the abovementioned information has been received the decision is notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment. 4. Surveillance 4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system. 4.2. The manufacturer authorizes the notified body to carry out all the necessary inspections and must supply it with all relevant information, in particular: — the documentation on the quality system, — the technical documentation, — the data stipulated in the part of the quality system relating to manufacture, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc. 4.3. The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the approved quality system and supply the manufacturer with an assessment report. 4.4. In addition, the notified body may pay unannounced visits to the manufacturer. At the time of such visits, the notified body may, where necessary, carry out or ask for tests in order to check that the quality system is working properly. It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. 5. Administrative provisions 5.1. The manufacturer or his or her authorised representative must, for a period ending at least five years, and in the case of implantable devices at least fifteen years, after the last product has been manufactured, make available to the national authorities: — the declaration of conformity, — the documentation referred to in the fourth indent of Section 3.1, — the changes referred to in Section 3.4, — the documentation referred to in the seventh indent of Section 3.1, — the decisions and reports from the notified body as referred to in Sections 4.3 and 4.4, — where appropriate, the type-examination certificate referred to in Schedule 3. 6. Application to devices in Class IIa In line with Article 11

(2)of Directive 93/42/EEC as amended, this Schedule may apply to products in Class IIa, subject to the following: 6.1. By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Schedule 7 and meet the requirements of Directive 93/42/EEC as amended which apply to them. 6.2. For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Schedule 7 for at least one representative sample for each device subcategory for compliance with the provisions of Directive 93/42/EEC as amended. 6.3. In choosing representative sample(
  1. s)the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with Directive 93/42/EEC as amended. The notified body shall document and keep available to the competent authority its rationale for the sample(
  2. s)taken. 6.4. Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3. 7. Application to devices referred to in Article 1
(4a)of Directive 93/42/EEC as amended. Upon completing the manufacture of each batch of devices referred to in Article 1
(4a)of Directive 93/42/EEC as amended, the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114
(2)of Directive 2001/83/EC SCHEDULE 6 EC DECLARATION OF CONFORMITY (Product quality assurance)
  1. The manufacturer must ensure application of the quality system approved for the final inspection and testing of the product, as specified in Section 3 and must be subject to the surveillance referred to in Section
  2. In addition, for products placed on the market in sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer must apply the provisions of Schedule 5, Sections 3 and
  4. The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of Directive 93/42/EEC as amended which apply to them. The manufacturer affixes

Article 17

of Directive 93/42/EEC as amended and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Schedule. 3. Quality system 3.1. The manufacturer lodges an application for assessment of his or her quality system with a notified body. The application must include: — the name and address of the manufacturer, — all the relevant information on the product or product category covered by the procedure, — a written declaration specifying that no application has been lodged with any other notified body for the same products, — the documentation on the quality system, — an undertaking by the manufacturer to fulfil the obligations imposed by the quality system approved, — an undertaking by the manufacturer to keep the approved quality system adequate and efficacious, — where appropriate, the technical documentation on the types approved and a copy of the EC type-examination certificates, — an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Schedule 10, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them: (

  1. i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his or her state of health; (
  2. ii)any technical or medical reason connected with the characteristics or the performance of a device for the reasons referred to in subparagraph (
  3. i)leading to a systematic recall of devices of the same type by the manufacturer. 3.2. Under the quality system, each product or a representative sample of each batch is examined and the appropriate tests defined in the relevant standard(
  4. s)referred to in Article 5 of Directive 93/42/EEC as amended or equivalent tests are carried out to ensure that the products conform to the type described in the EC type-examination certificate and fulfil the provisions of Directive 93/42/EEC as amended which apply to them. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written measures, procedures and instructions. This quality system documentation must permit uniform interpretation of the quality programmes, quality plans, quality manuals and quality records. It must include in particular an adequate description of: — the quality objectives and the organizational structure, responsibilities and powers of the managerial staff with regard to product quality, — the examinations and tests that will be carried out after manufacture; it must be possible to trace back the calibration of the test equipment adequately, — the methods of monitoring the efficient operation of the quality system, — the quality records, such as reports concerning inspections, tests, calibration and the qualifications of the staff concerned, etc., — where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party. The aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility. 3.3. The notified body audits the quality system to determine whether it meets the requirements referred to in section 3.2. It must presume that quality systems which implement the relevant harmonized standards conform to these requirements. The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers to inspect the manufacturing processes. The decision must be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment. 3.4. The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system. The notified body must assess the changes proposed and verify whether after these changes the quality system will still meet the requirements referred to in Section 3.2. After receiving the abovementioned information it must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment. 4. Surveillance 4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system. 4.2. The manufacturer must allow the notified body access for inspection purposes to the inspection, testing and storage locations and supply it with all relevant information, in particular: — the documentation on the quality system, — the technical documentation, — the quality records, such as inspection reports, test data, calibration data, qualification reports of the staff concerned, etc. 4.3. The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the quality system and must supply the manufacturer with an assessment report. 4.4. In addition, the notified body may pay unannounced visits to the manufacturer. At the time of such visits, the notified body may, where necessary, carry out or ask for tests in order to check that the quality system is working properly and that the production conforms to the requirements of the Directive which apply to it. To this end, an adequate sample of the final products, taken on site by the notified body, must be examined and the appropriate tests defined in the relevant standard(
  5. s)referred to in Article 5 of Directive 93/42/EEC as amended or equivalent tests must be carried out. Where one or more of the samples fails to conform, the notified body must take the appropriate measures. It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. 5. Administrative provisions 5.1. The manufacturer or his or her authorised representative must, for a period ending at least five years, and in the case of implantable devices at least fifteen years, after the last product has been manufactured, make available to the national authorities: — the declaration of conformity, — the documentation referred to in the seventh indent of Section 3.1, — the changes referred to in Section 3.4, — the decisions and reports from the notified body as referred to in the final indent of Section 3.4 and in Sections 4.3 and 4.4, — where appropriate, the certificate of conformity referred to in Schedule 3. 6. Application to devices in Class IIa In line with Article 11

(2)of Directive 93/42/EEC as amended, this Schedule may apply to products in Class IIa, subject to the following: 6.1. By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Schedule 7 and meet the requirements of Directive 93/42/EEC as amended which apply to them. 6.2. For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Schedule 7 for at least one representative sample for each device subcategory for compliance with the provisions of Directive 93/42/EEC as amended. 6.3. In choosing representative sample(
  1. s)the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with Directive 93/42/EEC as amended. The notified body shall document and keep available to the competent authority its rationale for the sample(
  2. s)taken. 6.4. Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3. SCHEDULE 7 EC DECLARATION OF CONFORMITY 1. The EC declaration of conformity is the procedure whereby the manufacturer or his or her authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of Directive 93/42/EEC as amended which apply to them. 2. The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his or her authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured. 3. The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. It must include in particular: — a general description of the product, including any variants planned and its intended use(s), — design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits, etc., — the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operations of the product, — the results of the risk analysis and a list of the standards referred to in Article 5 of Directive 93/42/EEC as amended, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in Article 5 of Directive 93/42/EEC as amended have not been applied in full, — in the case of products placed on the market in a sterile condition, description of the methods used and the validation report, — the results of the design calculations and of the inspections carried out, etc.; if the device is to be connected to other device(
  3. s)in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(
  4. s)having the characteristics specified by the manufacturer, — the solutions adopted as referred to in Schedule 1, Chapter I, Section 2, — the pre-clinical evaluation, — the clinical evaluation in accordance with Schedule 10, — the label and instructions for use. 4. The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Schedule 10, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He or she shall notify the competent authorities of the following incidents immediately on learning of them: (
  5. i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his or her state of health; (
  6. ii)any technical or medical reason connected with the characteristics on the performance of a device for the reasons referred to in subparagraph (
  7. i)leading to systematic recall of devices of the same type by the manufacturer. 5. With products placed on the market in sterile condition and Class I devices with a measuring function, the manufacturer must observe not only the provisions laid down in this Schedule but also one of the procedures referred to in Schedule 2, 4, 5 or 6. Application of the abovementioned Schedules and the intervention by the notified body is limited to: — in the case of products placed on the market in sterile condition, only the aspects of manufacture concerned with securing and maintaining sterile conditions, — in the case of devices with a measuring function, only the aspects of manufacture concerned with the conformity of the products with the metrological requirements. Section 6.1. of this Schedule is applicable. 6. Application to devices in Class IIa In line with Article 11
(2)of Directive 93/42/EEC as amended, this Schedule may apply to products in Class IIa, subject to the following derogation: 6.1. Where this Schedule is applied in conjunction with the procedure referred to in Schedule 4, 5 or 6, the declaration of conformity referred to in the abovementioned Schedules forms a single declaration. As regards the declaration based on this Schedule, the manufacturer must ensure and declare that the product design meets the provisions of Directive 93/42/EEC as amended which apply to it. SCHEDULE 8 STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES 1. For custom-made devices or for devices intended for clinical investigations the manufacturer or his or her authorized representative must draw up the statement containing the information stipulated in Section 2. 2. The statement must contain the following information: 2.1. for custom-made devices: — the name and address of the manufacturer, — data allowing identification of the device in question, — a statement that the device is intended for exclusive use by a particular patient, together with the name of the patient, — the name of the medical practitioner or other authorized person who made out the prescription and, where applicable, the name of the clinic concerned, — the specific characteristics of the product as indicated by the prescription, — a statement that the device in question conforms to the essential requirements set out in Schedule 1 and, where applicable, indicating which essential requirements have not been fully met, together with the grounds; 2.2. for devices intended for the clinical investigations covered by Schedule 10: — data allowing identification of the device in question, — the clinical investigation plan, — the investigator’>s brochure, — the confirmation of insurance of subjects, — the documents used to obtain informed consent, — a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Schedule 1, — a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, — the opinion of the ethics committee concerned and details of the aspects covered by its opinion, — the name of the medical practitioner or other authorized person and of the institution responsible for the investigations, — the place, starting date and scheduled duration for the investigations, — a statement that the device in question conforms to the essential requirements apart from the aspects covered by the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient. 3. The manufacturer must also undertake to keep available for the competent national authorities: 3.1. For custom-made devices, documentation, indicating manufacturing site(
  1. s)and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of Directive 93/42/EEC as amended. The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation mentioned in the first paragraph; 3.2. For devices intended for clinical investigations, the documentation must contain: — a general description of the product and its intended use, — design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc., — the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product, — the results of the risk analysis and a list of the standards referred to in Article 5 of Directive 93/42/EEC as amended, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of Directive 93/42/EEC as amended if the standards referred to in Article 5 of Directive 93/42/EEC as amended have not been applied, — if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Schedule 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, — if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection, — the results of the design calculations, and of the inspections and technical tests carried out, etc. The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section. The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures. 4. The information contained in the declarations concerned by this Schedule shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years. 5. For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Schedule 10, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions: (
  2. i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his or her state of health; (
  3. ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (
  4. i)leading to systematic recall of devices of the same type by the manufacturer. SCHEDULE 9 CLASSIFICATION CRITERIA I. DEFINITIONS 1. Definitions for the classification rules 1.1. Duration Transient Normally intended for continuous use for less than 60 minutes. Short term Normally intended for continuous use for not more than 30 days. Long term Normally intended for continuous use for more than 30 days. 1.2. Invasive devices Invasive device A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. Body orifice Any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma. Surgically invasive device An invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation. For the purposes of Directive 93/42/EEC as amended devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices. Implantable device Any device which is intended: — to be totally introduced into the human body or, — to replace an epithelial surface or the surface of the eye, by surgical intervention which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device. 1.3. Reusable surgical instrument Instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which can be reused after appropriate procedures have been carried out. 1.4. Active medical device Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand alone software is considered to be an active medical device. 1.5. Active therapeutical device Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap. 1.6. Active device for diagnosis Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. 1.7. Central circulatory system For the purposes of Directive 93/42/EEC as amended, ‘central circulatory system’ means the following vessels: arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior. 1.8. Central nervous system For the purposes of Directive 93/42/EEC as amended, ‘central nervous system’ means brain, meninges and spinal cord. II. IMPLEMENTING RULES 2. Implementing rules 2.1. Application of the classification rules shall be governed by the intended purpose of the devices. 2.2. If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used. 2.3. Software, which drives a device or influences the use of a device, falls automatically in the same class. 2.4. If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use. 2.5. If several rules apply to the same device, based on the performance specified for the device by the manufacturer, the strictest rules resulting in the higher classification shall apply. 2.6. In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means ‘an uninterrupted actual use of the device for the intended purpose’. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device. III. CLASSIFICATION 1. Non-invasive devices 1.1. Rule 1 All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies. 1.2. Rule 2 All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class IIa: — if they may be connected to an active medical device in Class IIa or a higher class, — if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues, in all other cases they are in Class I. 1.3. Rule 3 All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class IIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class IIa. 1.4. Rule 4 All non-invasive devices which come into contact with injured skin: — are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates, — are in Class IIb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent, — are in Class IIa in all other cases, including devices principally intended to manage the micro-environment of a wound. 2. Invasive devices 2.1. Rule 5 All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I: — are in Class I if they are intended for transient use, — are in Class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class I, — are in Class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in Class IIa. All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class IIa or a higher class, are in Class IIa. 2.2. Rule 6 All surgically invasive devices intended for transient use are in Class IIa unless they are: — intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III, — reusable surgical instruments, in which case they are in Class I, — intended specifically for use in direct contact with the central nervous system, in which case they are in Class III, — intended to supply energy in the form of ionising radiation in which case they are in Class IIb, — intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb, — intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb. 2.3. Rule 7 All surgically invasive devices intended for short-term use are in Class IIa unless they are intended: — either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III, — or specifically for use in direct contact with the central nervous system, in which case they are in Class III, — or to supply energy in the form of ionizing radiation in which case they are in Class IIb, — or to have a biological effect or to be wholly or mainly absorbed in which case they are in Class III, — or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class IIb. 2.4. Rule 8 All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended: — to be placed in the teeth, in which case they are in Class IIa, — to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III, — to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III, — or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III. 3. Additional rules applicable to active devices 3.1. Rule 9 All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy

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