EC: Updated Guide for Designation and Notification of Notified Bodies
The Medical Device Coordination Group (MDCG) has revised its guidance regarding the designation, re-assessment, and notification of conformity assessment bodies and notified bodies.
The MDCG consists of representatives from all EU Member States and is led by a representative of the European Commission (EC).
The updated guide aims to provide guidance to the authorities responsible for notified bodies and includes now provisions for conducting joint assessments by several authorities to expand the scope of designations. Based on experience gained in the context of the joint assessment process, the document has been updated, adding also clarification on the re-assessment process and notification procedure.
Source:
EC: New Regulations
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