# L_2011341EN.01006301.xml

| 22.12.2011 | EN | Official Journal of the European Union | L 341/63 |
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22.12.2011

EN

Official Journal of the European Union

L 341/63

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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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(1)

The common technical specifications for in vitro diagnostic 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. |
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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.

| (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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(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. |
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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.

| (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, |
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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

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(1)  
  OJ L 331, 7.12.1998, p. 1.

1

(2)  
  OJ L 131, 16.5.2002, p. 17.

2

(3)  See page 50 of this Official Journal.

3

(4)  
  OJ L 189, 20.7.1990, p. 17.

4

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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’

2.

‘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 |

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 |
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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 |
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—

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

| — | all available specimens shall be tested |
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—

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 %’

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