2007 – Council Directive 2007/47/EC

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The Council Directive 2007/47/EC has recently been released by which the Council Directive 93/42/EEC is amended. The amended directive becomes effective on 21 March 2010.
The amendments shall be implemented into national law as was the case with Council Directive 93/42/EEC.

Amending Directive 2007/47/EC: The directive became effective on 25 September 2007 and revises the directives 90/385/EEC (AIMDD), 93/42/EEC (MDD) and 98/8/EC (Biocidal Products). Among the changes there are the classification of software as a medical device, additional requirements on risks of usability and in general the adaptation of definitions, classifications and conformity assessment procedures.
In particular the regulations on the clinical evaluation have been reinforced by ANNEX X, concerning primarily the requirements on clinical data. Clinical data are also required for class I-products (Item 8). A clinical evaluation report according to Annex X provides evidence of the conformity with the essential requirements.

The Council Directive 93/42/EEC of 14 June 1993 concerning medical devices is one of a total three European Guidelines and the most important regulatory instrument for the safety and technical performance of medical devices in the European Economic Area.

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