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体外诊断试剂CE标准

II

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

DECISIONS

COMMISSION

COMMISSION DECISION

of 27 November 2009

amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices

(notified under document C(2009) 9464)

(Text with EEA relevance)

(2009/886/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community,

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 diag ­nostic medical devices are laid down in Commission Decision 2002/364/EC ( 2 ).

(2) In the interest of public health and in order to reflect technical progress including the evolution in the performance and analytical sensitivity of devices, it is appropriate to revise the common technical specifications laid down in Decision 2002/364/EC. (3) The definition of rapid test should be refined in order for it to be more precise. For the sake of clarity further definitions should be included. (4) To bring the common technical specifications in line with current scientific and technical practices it is necessary to update a number of scientific and technical references. (5) The requirements for HIV screening assays should be clarified. In order to ensure that the performance criteria appropriate to today’s technology is reflected in the common technical specifications it is necessary to add requirements for HIV antibody/antigen combined tests and further specification of the sample requirements for certain assays. (6) The Annex to Decision 2002/364/EC should therefore be amended accordingly and, for the purpose of clarity, be replaced. (7) Due to an administrative error, Commission Decision 2009/108/EC of 3 February 2009 amending Decision 2002/364/EC on common technical specifications for in vitro-diagnostic medical devices ( 3 ) was adopted without the European Parliament being given the possi ­bility to exercise its right of scrutiny in accordance with Article 8 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission ( 4 ). Therefore, Decision 2009/108/EC should be replaced by this Decision. (8) Manufacturers whose devices are already on the market should be given a transitional period in order to adapt to the new common technical specifications. On the other hand, in the interest of public health, manufacturers who so wish should be able to apply the new common technical specifications before the expiry of the transitional period.

(9) 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 ( 5

体外诊断试剂CE标准

),Journal of the European Union L 318/25

( 1 ) OJ L 331, 7.12.1998, p. 1. ( 2 ) OJ L 131, 16.5.2002, p. 17. ( 3 ) OJ L 39, 10.2.2009, p. 34. ( 4 ) OJ L 184, 17.7.1999, p. 23. ( 5 ) OJ L 189, 20.7.1990, p. 17.

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