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22.12.2011 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,
(5) The
measures
provided
for
in
this
Decision
are
in
accordance with the opinion of the committee set up
Having regard to the Treaty on the Functioning of the European
by Article 6(2) of Council Directive 90/385/EEC ( 4 ) and
Union,
referred to in Article 7(1) of Directive 98/79/EC,
Having regard to Directive 98/79/EC of the European
HAS ADOPTED THIS DECISION:
Parliament and of the Council of 27 October 1998 on in
vitro diagnostic medical devices ( 1 ), and in particular the
Article 1
second subparagraph of Article 5(3) thereof,
The Annex to Decision 2002/364/EC is amended in accordance
with the Annex to this Decision.
Whereas:
Article 2
(1) The
common
technical
specifications
for in vitro diag
nostic medical devices are laid down in Commission
This Decision shall apply from 1st of July 2012.
Decision 2002/364/EC ( 2 ).
However, Member States shall allow manufacturers to apply the
(2)
In the interest of public health it is appropriate, where
requirements set out in the Annex before the date set out in the
possible, to draw up common technical specifications for
first paragraph of this Article.
the devices listed in List A of Annex II to Directive
98/79/EC.
Article 3
(3)
Variant Creutzfeldt-Jakob disease (vCJD) assays for blood
This Decision is addressed to the Member States.
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 ).
Done at Brussels, 20 December 2011.
(4)
Taking into account the state of the art and the current
For the Commission
scientific knowledge on Variant Creutzfeldt-Jakob disease,
common technical specifications can be drawn up for
John DALLI
vCJD blood screening assays.
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.
( 4 ) OJ L 189, 20.7.1990, p. 17.

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L 341/64
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’
EN
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
24 replicates of each of three dilutions of the 23 of the 24 replicates detected at
reference number NHBY0/0003)
material WHO number NHBY0/0003
1×104
(1×104 , 1×105 , 1×106 )
Off
icial
vCJD spleen spikes in human plasma (10 % 24 replicates of each of three dilutions of the 23 of the 24 replicates detected at
spleen homogenate — NIBSC reference number material NIBSC number NHSY0/0009
Jour
NHSY0/0009)
1×10
(1×10, 1×102 , 1×103 )
nal
of
Diagnostic sensitivity A)
Specimen
from
appropriate
animal
models As
many
specimen
as
reasonably
possible
and
90 %
the
available, and at least 10 specimens
European
B) Specimen from humans with known clinical As many specimen as reasonably possible and
90 %
vCJD
available, and at least 10 specimens
Union
Only in case where 10 specimens are not no more than one false negative result
available:
— the number of specimens tested shall be
comprised between 6 and 9
— all available specimens shall be tested
Analytical specificity Potentially
cross-reacting
blood-specimens 100
Diagnostic specificity Normal
human
plasma
samples
from
area
of
low
5 000 At
least
99,5
%’
BSE exposure
22.12.2011

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