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

Deadlines Needed For Urgent EU MDR Vigilance And Postmarket Surveillance Guidance Documents

Executive Summary

Some 46 guidance documents still need to be drafted by the European Commission’s Medical Device Coordination Group before the EU MDR comes into force and time is running out, especially for postmarket responsibilities.

You may also be interested in...



Vigilance And Postmarket Surveillance: Companies Must Avoid Getting Caught Out By May 2021 Deadline

There is no choice: manufacturers must start EU MDR compliance now, however incomplete implementation is. And some MDR clauses apply to all products as of May 2021, regardless of the grace period.

Moves For Go Ahead For MDR Proposal To Be Discussed At European Parliament

The European Commission’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.

Notified Bodies Follow Expert Panel Opinions Under EU MDR To The Letter

A review of expert panel opinions related to high-risk medical devices shows no challenges yet by notified bodies to their findings.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT143007

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