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 (notified under document C(2019) 4632) (Text with EEA relevance.)

The Annex to Decision 2002/364/EC is amended in accordance with the Annex to this Decision.

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 ; (b) the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by this Decision.

This Decision is addressed to the Member States.