COMMISSION DECISION  
of 20 December 2011  
amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical 
devices  
(notified under document C(2011) 9398)  
(Text with EEA relevance)  
(2011/869/EU)  
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  diag ­
nostic medical devices are laid down in Commission 
Decision 2002/364/EC (  2 ). 
(2) In the interest of public health it is appropriate, where 
possible, to draw up common technical specifications for 
the devices listed in List A of Annex II to Directive 
98/79/EC.  
(3) Variant Creutzfeldt-Jakob disease (vCJD) assays for blood 
screening, diagnosis and confirmation have been added 
to List A of Annex II to Directive 98/79/EC by 
Commission Directive 2011/100/EU (  3 ). 
(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/EEC (  4 ) 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 amended in accordance 
with the Annex to this Decision.  
Article 2  
This Decision shall apply from 1st of July 2012.  
However, Member States shall allow manufacturers to apply the 
requirements set out in the Annex before the date set out in the 
first paragraph of this Article.  
Article 3  
This Decision is addressed to the Member States.  
Done at Brussels, 20 December 2011.  
For the Commission  
John DALLI  
Member of the CommissionEN 22.12.2011 Official Journal of the European Union L 341/63  
( 1 ) OJ L 331, 7.12.1998, p. 1.  
( 2 ) OJ L 131, 16.5.2002, p. 17.  
( 3 ) See page 50 of this Official Journal.  (  4 ) OJ L 189, 20.7.1990, p. 17.ANNEX  
1. The following section is added at the end of Section 3 of the Annex to Decision 2002/364/EC:  
‘3.7.  CTS for Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening  
CTS for Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening are set out in Table 11’  
2. The following table is added at the end 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  
Analytical sensitivity  vCJD brain spikes in human plasma (WHO 
reference number NHBY0/0003)  24 replicates of each of three dilutions of the 
material WHO number NHBY0/0003 
(1×104 , 1×105 , 1×106 ) 23 of the 24 replicates detected at 
1×104 
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 
(1×10, 1×102 , 1×103 ) 23 of the 24 replicates detected at 
1×10  
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 %  
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 %’EN L 341/64 Official Journal of the European Union 22.12.2011