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^f1;

(b)

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices^f2 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^f3 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.”