Address https://gelex.eu/eli/EU/decision/2011/869@2011-12-20/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
   3. Article 3
3. ANNEX
4. ANNEX 1.2. Table 11 A)B) Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening
5. ANNEX 1.

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, 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) 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.

(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 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 Commission

ANNEX

ANNEX 1.2. Table 11 A)B) Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening

The following section is added at the end of Section 3 of the Annex to Decision 2002/364/EC: The following table is added at the end of the Annex to Decision 2002/364/EC: 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 Specimen from appropriate animal models As many specimen as reasonably possible and available, and at least 10 specimens 90 % 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: 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 5000 At least 99,5 %

ANNEX 1.

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

the number of specimens tested shall be comprised between 6 and 9

all available specimens shall be tested

Versions

1. 2011-12-20

Cited by

• 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 (notified under document C(2019) 4632) (Text with EEA relevance) Decision · Grade B

  the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by Commission Decision 2011/869/EU;

• Commission Implementing Decision (EU) 2020/350 of 28 February 2020 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 (notified under document C(2020) 1086) (Text with EEA relevance) Decision · Grade B

  the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Decision 2011/869/EU;

• Council Decision (EU) 2026/1535 of 25 June 2026 on the position to be adopted on behalf of the European Union within the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco concerning amendments to the Annex to that Agreement Decision · Grade B

  Commission Decision 2011/869/EU of 20 December 2011 (OJ L 341, 22.12.2011, p. 63);

• Council Decision of 9 July 2013 on the position to be adopted, on behalf of the European Union, in the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco (2013/455/EU) Decision · Grade B

  Commission Decision 2011/869/EU of 20 December 2011 (OJ L 341, 22.12.2011, p. 63).