EN    EN EN 
  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2010) yyy final 
  
Draft 
COMMISSION DECISION 
of […] 
amending Decision 2002/364/EC on common technical specifications for in vitro  
diagnostic medical devices  
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION DECISION 
of […] 
amending Decision 2002/364/EC on common technical specifications for in vitro 
diagnostic medical devices  
(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) 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 h ealth it is appropriate, wher e possible, to draw up common 
technical specifications for th e devices listed in List A of Annex II to Directive 
98/79/EC. 
(3) Variant Creutzfeldt-Jakob disease (vCJD) a ssays for blood screen ing, diagnosis and 
confirmation have been added to List A of Annex II to Directive 98/79/EC by 
Commission Directive … . 
(4) Taking into account the state of the art and the current scientific  knowledge on Variant 
Creutzfeldt-Jakob disease, common technical specifications can be drawn up for vCJD 
blood screening assays. 
(5) The measures provided for in this Decision are in accordance with the opinion of the 
committee set up by Article 6(2) of Council Directive 90/385/EEC3 and referred to in 
Article 7(1) of Directive 98/79/EC, 
HAS ADOPTED THIS DECISION:  
Article 1 
The Annex to Decision 2002/364/EC is amende d in accordance with the Annex to this 
Decision. 
                                                 
1 OJ L 331, 7.12.1998, p. 1. 
2 OJ L 131, 16.5.2002, p. 17. 
3 OJ L 189, 20.7.1990, p. 17.  
EN 3   EN Article 2  
This Decision shall apply from [application date of the parallel Commission Directive]. 
However, Member States shall allow manufacturers to apply th e requirements set out in the 
Annex before the date set out in th e first paragraph of this Article. 
Article 3 
This Decision is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 […]  Member of the Commission   
EN 4   EN ANNEX  
The following table is added at the e nd of the Annex to Decision 2002/364/EC: 
 "Table 11: Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening  
 
 Material   Number of specimens  Acceptance Criteria  
vCJD brain spikes in human 
plasma (WHO reference number 
NHBYO/003) 
  24 replicates of each of three 
dilutions of the material WHO 
number NHBYO/003 
(1x10
4, 1x105, 1x106)  
 23 of the 24 replicates detected at  
1x 104 Analytical sensitivity  
 
vCJD spleen spikes in human 
plasma (10% spleen homogenate - 
NIBSC reference number 
NHSY0/0009) 
  24 replicates of each of three 
dilutions of the material NIBSC 
number NHSY0/0009 
(1x10, 1x10
2 , 1x103)  
 23 of the 24 replicates detected at  
1x 10 
Diagnostic sensitivity 
 A) Specimen from appropriate 
animal models As many specimen as reasonably 
possible and available, and at 
least 10 specimens 90%  
 B) Specimen from humans with 
known clinical vCJD As many specimen as reasonably 
possible and available, and at 
least 10 specimens 
 90%  
EN 5   EN Only in case where 10 
specimens are not available: 
 
- the number of specimens tested 
shall be comprised between 6 
and 9  
- all available specimens shall be 
tested no more than one false negative result 
Analytical specificity 
 Potentially cross-reacting 
blood-specimens 100  
Diagnostic specificity  
 
 
 Normal human plasma samples 
from area of low BSE exposure 5,000 
 At least 99.5%