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)

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

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

This Decision is addressed to the Member States.