OpenLegislation

Article 2

United Kingdom

Original text. Later amendments are not shown.

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:

  1. (a)

    the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by Commission Decision 2011/869/EUf1;

  2. (b)

    the common technical specifications laid down in the Annex to 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).