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Document 32011D0869
2011/869/EU: 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: 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: 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
OJ L 341, 22.12.2011, p. 63–64
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV) This document has been published in a special edition(s)
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Official Journal
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22.12.2011 |
EN |
Official Journal of the European Union |
L 341/63 |
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 diagnostic medical devices are laid down in Commission Decision 2002/364/EC (2). |
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(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. |
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(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). |
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(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. |
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(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 Commission
(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.
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
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Material |
Number of specimens |
Acceptance Criteria |
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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 |
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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 |
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Diagnostic sensitivity |
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As many specimen as reasonably possible and available, and at least 10 specimens |
90 % |
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As many specimen as reasonably possible and available, and at least 10 specimens |
90 % |
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Only in case where 10 specimens are not available:
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no more than one false negative result |
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Analytical specificity |
Potentially cross-reacting blood-specimens |
100 |
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Diagnostic specificity |
Normal human plasma samples from area of low BSE exposure |
5 000 |
At least 99,5 %’ |