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Commission Recommendation on the audits and assessments performed by notified bodies in the field of medical devices

October 1st, 2013

Although just a “recommendation” this document issued by the EU Commission on Sept. 24th can be considered a “soft” regulation of which implementation has already started even before its publication. At this point any talk of “transition period” doesn’t make sense. The recommendation is out and the Competent Authorities of the EU Member States, to which it is addressed, have already started to follow it.

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The Qarad Team