# 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), Article 2

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eudn/2020/350/article/2 (the official version)
Page: https://openlegislation.uk/eu-decision-2020-350/article-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.