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

EU MDR Standards Delay: MedTech Europe Offers A Pragmatic Way Forward

Executive Summary

Standards harmonized under the EU medical device directives may have more longevity than originally expected, given the delay in the readiness of standards that can be used in the context of the forthcoming Medical Device Regulation.

You may also be interested in...



First Harmonized Standards Published For Both MDR And IVDR

After a long delay, the EU’s first harmonized standards under the MDR and IVDR are trickling through ̶ but the standards situation is still far from ideal.

Medtech Standards Request Advances – But Too Late For MDR/IVDR First Wave

The medtech sector may, at last, be one step closer to ensuring standards are drafted or revised under the EU’s MDR and IVDR. But delays have already meant industry has had to adopt “Plan B.”

Commission Invites European Standards Bodies To Accept MDR/IVDR Standardization Request

The European Commission has at last officially requested that CEN and CENELEC develop and update urgently needed standards to support the MDR and IVDR. The pressure is now on the national European standards bodies to press on with the necessary work.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT142277

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