Commission Implementing Decision (EU) 2019/1244 Article 2

Article 2

This Decision shall apply from 2 July 2020. Until that date, Member States shall apply the presumption of compliance referred to in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with either of the following specifications: (a) the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by Commission Decision 2011/869/EU ( 4 ) ; (b) the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by this Decision.

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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) 2019/1244 (LawPlayer, data as of 2026-07-04)

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