S.I. No. 691/2021 - Medical Devices (Registration) Regulations 2021 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English
the Active Implantable Devices Directive, as applicable, pursuant to Article 120
(3)of the Medical Devices Regulation.
(2)A manufacturer who, having his or her established place of business in the State, places a device on the market under his or her own name shall, in the manner prescribed by the Authority— (
- a)notify the Authority of his or her name and registered place of business, and (
- b)supply the Authority with a description of the device which is sufficient to identify it.
(3)A manufacturer who, having designated an authorised representative which has his or her established place of business in the State, places a device on the market shall, in the manner prescribed by the Authority— (
- a)notify the Authority of his or her name and registered place of business, (
- b)supply the Authority with a description of the device which is sufficient to identify it, and (
- c)furnish the Authority with sufficient evidence to establish that he or she has designated his or her authorised representative in respect of the device concerned in accordance with Article 11 of the Medical Devices Regulation, Article 11 of the IVD Medical Devices Regulation, Article 14
(2)of
Article 10a(2) of the Active Implantable Medical Devices Directive, as applicable.
(4)An authorised representative who, having his or her established place of business in the State, places a device on the market shall, in the manner prescribed by the Authority— (
- a)notify the Authority of his or her name and registered place of business, (
- b)supply the Authority with a description of the device which is sufficient to identify it, and (
- c)furnish the Authority with sufficient evidence to establish that he or she has been designated by the manufacturer as his or her authorised representative in respect of the device concerned in accordance with Article 11 of the Medical Devices Regulation, Article 11 of the IVD Medical Devices Regulation, Article 14
(2)of
Article 10a(2) of the Active Implantable Medical Devices Directive, as applicable.
Additional registration requirements in relation to devices other than IVD devices 4.
(1)This Regulation applies to devices, other than custom-made devices, placed on the market in the European Economic Area in accordance with— (a) the Medical Devices Regulation, or (b)
the Active Implantable Devices Directive, as applicable, pursuant to Article 120
(3)of the Medical Devices Regulation.
(2)An importer who, having his or her established place of business in the State, places a device on the market shall, in the manner prescribed by the Authority— (
- a)notify the Authority of— (
- i)his or her name and registered place of business, (
- ii)the name and registered place of business of the manufacturer of the device, and (iii) the name and registered place of business of the authorised representative designated by the manufacturer of the device, and (
- b)supply the Authority with information relating to the category of the device.
(3)A distributor who, having his or her established place of business in the State, places a device on the market shall, in the manner prescribed by the Authority— (
- a)notify the Authority of his or her name and registered place of business, and (
- b)supply the Authority with information relating to the category of the device. Registration requirements in relation to custom-made devices 5. A manufacturer who, having his or her established place of business in the State, places a custom-made device on the market in the European Economic Area, in accordance with Article 52
(8)of the Medical Devices Regulation, Article 11
(6)of
Article 9
(2)of the Active Implantable Medical Devices Directive, shall, in the manner prescribed by the Authority— (
- a)notify the Authority of his or her name and place of business, and (
- b)supply the Authority with a description of the device which is sufficient to identify it. Registration requirements in relation to systems and procedure packs 6. Any person who, having his or her established place of business in the State, places a system or procedure pack on the market in the European Economic Area in accordance with Article 22 of the Medical Devices Regulation or Article 12 of the Medical Devices Directive shall, in the manner prescribed by the Authority— (
- a)notify the Authority of his or her name and registered place of business, and (
- b)supply the Authority with a description of the system or procedure pack which is sufficient to identify it. Registration requirements in relation to health institutions 7. A health institution in the State which manufactures and uses an in-house device within that institution shall, in the manner prescribed by the Authority— (
- a)notify the Authority of its name and address, and (
- b)supply the Authority with information about the in-house device on request. Registration requirements in relation to manufacturing facilities 8. A manufacturing facility in the State shall, in the manner prescribed by the Authority— (
- a)notify the Authority in writing of the name and address of the facility, and (
- b)supply the Authority with information regarding the activity relating to devices carried out in the facility. GIVEN under my Official Seal, 9 December, 2021. STEPHEN DONNELLY, Minister for Health. EXPLANATORY NOTE (This note is not part of the Instrument and does not purport to be a legal interpretation.) These Regulations are made under section 32 of the Irish Medicines Board Act 1995 and provide for registration requirements in relation to medical devices, and other devices, placed on the market in the State. These Regulations may be cited as the Medical Devices (Registration) Regulations 2021. 1 OJ No. L 189, 20.7.1990, p. 17. 2 OJ No. L 220, 30.8.1993, p. 1. 3 OJ No. L 284, 31.10.2003, p. 1. 4 OJ No. L 247, 21.9.2007, p. 21. 5 OJ No. L 117, 5.5.2017, p. 176. 6 OJ No. L 189, 20.7.1990, p. 17. 7 OJ No. L 331, 7.12.1998, p. 1. 8 OJ No. L 313, 13.12.2000, p. 22. 9 OJ No. L 6, 10.1.2002, p. 50. 3 OJ No. L 284, 31.10.2003, p. 1. 4 OJ No. L 247, 21.9.2007, p. 21. 10 OJ No. L 117, 5.5.2017, p. 1. 11 OJ No. L 130, 24.4.2020, p. 18. Privacy Statement Accessibility European Legislation Identifier (PDF) Open Data License Ráiteas Príobháideachais Inrochtaineacht Aitheantóir Eorpach Reachtaíochta (ELI) Ceadúnas Sonraí Oscailte Liosta Fianán © Government of Ireland. Oireachtas Copyright Material is reproduced with the permission of the Houses of the Oireachtas © Rialtas na hÉireann. Atáirgtear ábhar faoi Chóipcheart le cead ó Thithe an Oireachtais