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 EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (1), and in particular the second subparagraph of Article 5(3) thereof,

Whereas:

(1) Pursuant to Article 5(3) of Directive 98/79/EC, Member States are to presume compliance with the essential requirements referred to in Article 3 of that Directive in respect of devices designed and manufactured in conformity with common technical specifications. The common technical specifications for in vitro diagnostic medical devices are laid down in Commission Decision 2002/364/EC (2).

(2) In the interest of public health and patient safety and in order to reflect scientific and technological progress, including the evolution in the intended use, performance and analytical sensitivity of certain devices, it is appropriate to further revise the common technical specifications laid down in Decision 2002/364/EC.

(3) Taking into account the evolving state of the art, changing clinical needs, growing scientific knowledge, and the new types of devices present on the market, the common technical specifications should be amended with respect to the requirements for HIV and hepatitis C virus (HCV) antigen and antibody combined tests, as well as the requirements for nucleic acid amplification techniques as regards reference materials and qualitative HIV assays.

(4) The manufacturers should be allowed time to adapt to the new common technical specifications. The date of application of the requirements laid down in this Decision should therefore be deferred. However, in the interest of public health and patient safety, manufacturers should be allowed to follow the new common technical specifications before the date of application on a voluntary basis.

(5) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 6(2) of Council Directive 90/385/EEC (3),

HAS ADOPTED THIS DECISION:

Article 1 The Annex to Decision 2002/364/EC is amended in accordance with the Annex to this Decision.

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.

Article 3 This Decision is addressed to the Member States.

Done at Brussels, 1 July 2019. For the Commission Elżbieta BIEŃKOWSKA Member of the Commission

(1) OJ L 331, 7.12.1998, p. 1.

(2) Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16.5.2002, p. 17).

(3) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).

(4) 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).