PART 2Amendment of Regulation (EC) No 1907/2006
Article 33
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 20023;
b
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices4 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 devices5 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.