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

Time For Talking: MedTech Europe Wants Clarity And Transparency Over MDR Amendment

Executive Summary

The MDR amending regulation is on the cusp of being enforced. Most feel it is long overdue to prevent further medtech regulatory chaos in the EU. But the new text raises many questions itself. Medtech Insight spoke to MedTech Europe’s Petra Zoellner to understand what is needed next.

You may also be interested in...



Official Sign-Off For EU Medical Device Regulation Amending Text Due Today

The first legal stages in the process for implementing new rules that will extend the Medical Device Regulation transitional period and remove the one-year sell-off period conditions are nearly complete. But further work will be needed.

EU Regulatory Round-Up, March 2023: EU Deadlines Under MDR Amending Regulation Published And Clarified

This month’s round-up summarises the biggest EU medtech regulatory news in a year as legacy device transition periods are extended. A highly applauded commission summary of the new timelines under the EU’s MDR amending regulation provides key snapshot of the essential points.

Why Adding A Legacy Device To Eudamed Now, Before It is Mandatory, Is A Shrewd Move

The EU MDR amending regulation does not impact Eudamed directly, but it may make medtech manufacturers reconsider when to register legacy devices in Eudamed. Richard Houlihan of EirMed explains.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT147738

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