My bookmarksSign up free

Commission Implementing Decision (EU) 2020/350 Article 2

Commission Implementing Decision (EU) 2020/350 Article 2

Article 2

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  ( 4 ) ; (b) the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Implementing Decision (EU) 2019/1244  ( 5 ) ; (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.

Read the full instrument →

Other provisions in Commission Implementing Decision (EU) 2020/350

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 2 of Commission Implementing Decision (EU) 2020/350 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

What to look at next