
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 Commission
ANNEX
1. 
' 3.7. 
CTS for Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening are set out in Table 11
'

2. 
'
 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 at1×104
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 at1×10
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 %'
