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Easy Links To Essential Pages On The European Commission’s Medical Device Website

Executive Summary

New documents and links related to the Medical Device and IVD Regulations are published by the European Commission almost daily. Here is a quick guide to where to find the information you need.

Quickly finding the correct European Commission’s webpage to access information relating to the new Medical Device and IVD Regulations is not always easy. The website is now heavily populated with information and forever expanding; navigating it can be like finding your way through a maze.

Here are some quick links to essential information you may need in one handy guide:

Quick Links To Key European Commission’s MDR and IVDR webpages

 

Medical Device Regulation (EU) 2017/745 (MDR)

IVD Regulation (EU) 2017/746 (IVDR)

List of notified bodies designated under the MDR

List of notified bodies designated under the IVDR

MDR expert panel opinions

IVDR expert panel opinions

Implementing and delegated acts

Guidance documents

MDR/IVDR Harmonized standards

Ongoing guidance deliverables

Implementation rolling plan

MDR/IVDR MDCG working groups agenda

 

There was also a flurry of documents published by the notified body association, TEAM-NB, in October that are intended to support the implementation of the MDR and IVDR. They are available here.

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