Article 2
United Kingdom
This Decision shall apply from 2 March 2021.
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:
the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Decision 2011/869/EUf1;
the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Implementing Decision (EU) 2019/1244f2;
the common technical specifications laid down in Decision 2002/364/EC as amended by this Decision.
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:
the common technical specifications laid down in Decision 2002/364/EC as amended by Implementing Decision (EU) 2019/1244;
the common technical specifications laid down in Decision 2002/364/EC as amended by this Decision.
Annotations
Footnotes
- f1
-
Commission Decision 2011/869/EU of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (OJ L 341, 22.12.2011, p. 63).
- f2
-
Commission Implementing Decision (EU) 2019/1244 of 1 July 2019 amending Decision 2002/364/EC as regards requirements for HIV and HCV antigen and antibody combined tests and as regards requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays (OJ L 193, 19.07.2019, p.1).