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

• CELEX: Decision 2002/364/EC
• Articles: 4

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.

Schedules & Appendices

ANNEX

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

(1×10 4 , 1×10 5 , 1×10 6 )

23 of the 24 replicates detected at

1×10 4

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, 1×10 2 , 1×10 3 )

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 %’