EU publishes several new & Revised MEDDEV guidance documents (FEB 2012)

bio_subbu

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Dear All

The European Commission has published several new & Revised guidance documents in the MEDDEV series. Please refer below;

1. (MEDDEV 2.1/6) Qualification and Classification of stand alone software

2. (MEDDEV 2.2/4) Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products

3. (MEDDEV 2.5/10) Guideline for Authorised Representatives

4. (MEDDEV 2.14/1 Rev.2) IVD Borderline and Classification issues. A guide for manufacturers and notified bodies

5. (MEDDEV 2.14/4) CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP

Regards
S.Subramaniam
 

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