Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Much More Is Needed, Industry Says In Response To EU's 19-Point Regulatory Action Plan

Executive Summary

The new EU Medical Device and IVD Regulations are reaching a critical tipping point. The 19-point plan just released is not going to cut it, medtech players fear. Is this really the lifeline needed for the medtech industry?

You may also be interested in...



EU Medtech Industry Awaits Outcome Of MDCG’s Urgent Meeting With Bated Breath

Will the EU agree that Article 97 is the way to go to avoid notified body bottlenecks in the context of the Medical Device Regulation? This matter is now being reviewed at the highest levels.

French Government Will Tell Commission To Give Notified Bodies Time To Process All Files

Despite proposals to alleviate the threat of medtech products being unnecessarily removed from the EU market when their old certificates expire, concerns remain at the highest level and calls for action persist.

MDCG Listens To Industry Over New Medtech Regulation Hurdles And Publishes 19-Point Action Plan

The medtech sector will be relieved to see this latest document relating to the implementation of the EU’s Medical Device and IVD Regulation. Its concrete proposals address multiple concerns.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145781

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