Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

EU One Step Closer To Confirming EMA's New Pivotal Role In Device Matters

Executive Summary

Industry opposes the proposed new role of European Medicines Agency in overseeing devices availability in a healthcare crisis. But a new Regulation may be adopted in March and its fallout looks set to herald a new era for device supply management and regulation.

You may also be interested in...



Proposal For EMA To Provide Medtech Expert Panel Structure Gains Traction

The medtech industry has long resisted having the European Medicines Agency involved in device oversight. Now an EU-level proposal is making device makers nervous.

European Regulatory Roundup, November 2021: Eudamed Dominates News

Updates and speculation surrounding the Eudamed medtech database has attracted significant attention in November. It was also an impactful month for IVDR news too, and for moves strengthening the medtech and pharma interface.

Commission Publishes Implementing Regulation That Acts As Basic Starter Manual For Eudamed

The European Commission has published an Implementing Regulation explaining some of the fundamental practices that need to be carried out by different actors from the beginning for Eudamed to operate successfully.

Topics

UsernamePublicRestriction

Register

MT144687

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel