Article 3
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(1);
(b)Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices(2) 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(3) 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.”
S.I. 2002/618, amended by S.I. 2003/1400, 1697, 2005/2759, 2909, 2007/400, 610, 803, 2008/530, 2936, 2009/383, 2010/557, 2012/1426, 2013/525, 2327, 2017/207, 2019/791.
OJ No. L 117, 5.5.2017, p. 1, as last amended by Regulation 2020/561 (OJ No. L 130, 24.4.2020, p. 18).
OJ No. L 117, 5.5.2017, p. 16, as last corrected by Corrigendum (OJ No. L 334, 27.12.2019, p. 167).