EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION  
of XXX  
amending Decision 2002/364/EC as regards definitions of first –line assays and 
confirmatory assays, requirements for devices for self -testing and requirements for HIV 
and HCV rapid tests, confirmatory and supplementary assays  
(Text with EEA relevance)   EN 2  EN COMMISSION IMPLEMENTING DECISION  
of XXX  
amending Decision 2002/364/EC as regards definitions of first –line assays and 
confirmatory assays, requirements for devices for self -testing and requirements for HIV 
and HCV rapid tests, confirmatory and supplementary 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 s econd 
subparagraph of Article 5(3) thereof,   
Whereas:  
(1) Pursuant to the first subparagraph of 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 update  the comm on 
technical specifications laid down in Decision 2002/364/EC.  
(3) The definitions of first -line assays and confirmatory assays, requirements for devices 
for self -testing and requirements for HIV and HCV rapid tests , confirmatory and 
supplementary assays  shoul d be amended in order to take into account the evolv ed 
state of the art, the chang es in clinical needs, new scientific knowledge  available  and 
the new types of devices present on the market .  
(4) The manufacturers should be allowed time to adapt to the changes  in common 
technical specifications. The date of application of this Decision should therefore be 
deferred. However, in the interest of public health and patient safety, manufacturers 
should be allowed to comply with  the common technical specifications as amended by 
this Decision  before its 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 3  EN HAS ADOPTED THIS DEC ISION:  
Article 1  
The Annex to Decision 2002/364/EC is amended in accordance with the Annex to this 
Decision.  
Article 2  
1. This Decision shall apply from … [12 months after the date of notification of this 
Decision ].  
2. Notwithstanding paragraph 1, from … [ the date of notification of this Decision ] until  2 
July 2020  Member States shall apply the presumption of compliance laid down in 
Article 5(3) of Directive 98/79/EC for all in vitro  diagnostic medical devices that 
comply with any of the following:  
(a) the common technical specifications laid down in Decision 
2002/364/EC as amended by Commission Decision 2011/869/EU4; 
(b) the common technical specifications laid down in Decision 
2002/364 /EC as amended by Commission Implementing Decision (EU) 
2019/12445; 
(c) the common technical specifications laid down in Decision 
2002/364/EC as amended by this Decision.  
3. Notwithstanding paragraph 1, from 2 July 2020 until … [ 12 months after the date of 
notification of this Decision ] Member States shall apply the presumptio n of 
compliance laid down in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic 
medical devices that comply with either of the following:  
(a) the common technical specifications laid down in Decision 
2002/364/EC as amended by Commission Impleme nting Decision (EU) 
2019/1244;  
(b) the common technical specifications laid down in Decision 
2002/364/EC as amended by this Decision.  
Article 3 
This Decision is addressed to the Member States.  
Done at Brussels,  
 For the Commission  
 Elżbieta Bień kowska  
 Member of the Commission  
                                                 
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 ). 
5  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 (OJ L 193, 19.07.2019, p.1 ).