Commission Implementing Decision (EU) 2020/350 of 28 February 2020 amending Decision 2002/364/EC as regards definitions of first–line assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays (notified under document C(2020) 1086) (Text with EEA relevance) (c. 350)

Article 1 U.K.

The Annex to Decision 2002/364/EC is amended in accordance with the Annex to this Decision.

Article 2 U.K.

1. This Decision shall apply from 2 March 2021.

2. Notwithstanding paragraph 1, from 2 March 2020 until 1 July 2020 Member States shall apply the presumption of compliance laid down in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with any of the following:

(a) the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Decision 2011/869/EU(1);

(b) the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Implementing Decision (EU) 2019/1244(2);

(c) the common technical specifications laid down in Decision 2002/364/EC as amended by this Decision.

3. Notwithstanding paragraph 1, from 2 July 2020 until 1 March 2021 Member States shall apply the presumption of compliance laid down in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with either of the following:

(a) the common technical specifications laid down in Decision 2002/364/EC as amended by Implementing Decision (EU) 2019/1244;

(b) the common technical specifications laid down in Decision 2002/364/EC as amended by this Decision.

Article 3 U.K.

This Decision is addressed to the Member States.

Done at Brussels, 28 February 2020.

For the Commission

Stella Kyriakides

Member of the Commission