EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION  
of XXX  
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  
(Text with EEA re levance)   EN 1  EN COMMISSION IMPLEMENTING DECISION  
of XXX  
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  
(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 devices1, 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/EC2. 
(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 2002/36 4/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 antib ody combined tests , as well as the 
requirements for nucleic acid a mplification 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/EEC3, 
                                                 
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).  EN 2  EN 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 … [12 months after notification ].  
Until that date, Member States shall apply the pre sumption 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 . 
.Article 3 
This Decision is addressed to the Member States.  
Done at Brussels,  
 For the Commissio n 
 Elżbieta Bień kowska  
 Member of the Commission