# The REACH etc. (Amendment) Regulations 2021, Regulation 3: Article 3


In Article 3 (definitions), after paragraph 43 insert—
“44. relevant medical device: means a medical device within the scope of—
(a) the Medical Devices Regulations 2002;
(b) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices as it has effect in EU law; or
(c) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices as it has effect in EU law;
45. relevant accessory to a medical device: means an accessory to a medical device within the scope of—
(a) the Medical Devices Regulations 2002;
(b) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices as it has effect in EU law; or
(c) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices as it has effect in EU law.”

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Source: https://www.legislation.gov.uk/uksi/2021/904/regulation/3 (the official version)
Page: https://openlegislation.uk/reach-etc-amendment-regulations-2021/regulation-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.