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PR(06)07: Iceland fails to fully implement detailed rules on medical devices manufactured from materials of animal origin

1.3.2006

The EFTA Surveillance Authority today delivered a reasoned opinion to Iceland for failing to fully implement Directive 2003/32/EC. The Directive should have been implemented into national law by 9 June 2004.

Directive 2003/32/EC amends Directive 93/42/EEC. Whereas Directive 93/42/EEC lays down the essential requirements for medical devices in general, Directive 2003/32/EC sets out detailed specifications concerning the essential requirements that medical devices of animal origin must meet, and specifies certain aspects relating to the risk analysis and risk management of such devices.

The purpose of a reasoned opinion is to give the State in question a last chance to take corrective measures before the Authority decides whether to bring the matter before the EFTA Court. Iceland has been given two months to take the measures necessary to comply with the reasoned opinion. 


For further information, please contact:
Mr. Hallgrímur Ásgeirsson
Director, Internal Market Affairs Directorate
Tel. (+32)(0)2 286 18 60

1 March 2006




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