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MDD RECAST

The Notified Bodies around the world are preparing themselves for the new upcoming MDD regulations recast. The regulation was published on 26th September 2012 includes the new EU regulations on all medical devices. The final regulation is likely to be released in 2014.

The changes would reflect:

v  The new EU regulation structure and system

v  Conformity assessment procedures

v  Consequence for Notified Bodies, Authorised Representatives, Importers and Distributors

v  Requirements related to implementation, planning and documentation

v  Unique Device Identification (UDI)

v  CE marking procedure for medical devices

v  Management system in accordance with EN ISO 13485; Fundamental principles, Interface with International regulatory requirements, Differences to EN ISO 9001

v  Technical file for Medical  Devices; Overview of contents and structure

v  Clinical evaluation of Medical Devices; New regulations for Europe.

Advena will keep informing you about these summarizes with regular updated blogs.

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