HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 341/50
EN
Official Journal of the European Union
22.12.2011
DIRECTIVES
COMMISSION DIRECTIVE 2011/100/EU
of 20 December 2011
amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic
medical devices
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Article 2
1. Member
States
shall
adopt
and
publish
the
laws,
regu
Having regard to the Treaty on the Functioning of the European
lations and administrative provisions necessary to comply
Union,
with this Directive by 30 June 2012 at the latest. They shall
forthwith communicate to the Commission the text of those
Having regard to Directive 98/79/EC of the European
provisions.
Parliament and of the Council of 27 October 1998 on in-
vitro diagnostic medical devices
( 1 ), and in particular
Member States shall apply those provisions from 1 July 2012.
Article 14 thereof,
Whereas:
When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
(1) In
accordance
with
Article
14(1)(a)
of
Directive States shall determine how such reference is to be made.
98/79/EC, the United Kingdom has requested that the
Commission take the necessary measures to add
‘Variant Creutzfeldt-Jakob disease’ (vCJD) assays to List
2. Member
States
shall
communicate
to
the
Commission
the
A of Annex II to that Directive.
text of the main provisions of national law which they adopt in
the field covered by this Directive.
(2) In
order
to
ensure
the
highest
level
of
health
protection
and ensure that the conformity of vCJD assays with the
essential requirements set out in Annex I to Directive
Article 3
98/79/EC is verified by notified bodies, vCJD assays for
This Directive shall enter into force on the 20th day following
blood screening, diagnosis and confirmation should be
its publication in the Official Journal of the European Union.
added to List A of Annex II to Directive 98/79/EC.
Article 4
(3) The
measures
provided
for
in
this
Directive
are
in
accordance with the opinion of the Committee set up
This Directive is addressed to the Member States.
by Article 6(2) of Council Directive 90/385/EEC ( 2 ) and
referred to in Article 7(1) of Directive 98/79/EC,
Done at Brussels, 20 December 2011.
HAS ADOPTED THIS DIRECTIVE:
Article 1
For the Commission
Annex II to Directive 98/79/EC is amended in accordance with
The President
the Annex to this Directive.
José Manuel BARROSO
( 1 ) OJ L 331, 7.12.1998, p. 1.
( 2 ) OJ L 189, 20.7.1990, p. 17.

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EN
22.12.2011 Official
Journal
of
the
European
Union L
341/51
ANNEX
The following indent is added at the end of List A of Annex II to Directive 98/79/EC:
‘— Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation.’

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