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


New Voices Clamor For Urgent MDR Action To Avoid Major Clinical Crisis

Executive Summary

Industry and notified bodies have long warned of the hurdles to implementation of the Medical Device Regulation. Now competent authorities and medical and research societies are adding to the pressure for the EU to find solutions fast.  

You may also be interested in...

MDCG Throws Ball Back Firmly In Manufacturers' Court As Pressure Grows For MDR Solutions

EU manufacturers who delay applying to notified bodies for conformity assessment of their medtech products well in advance are being held accountable for implementation problems with the EU Medical Device Regulation.

EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions

It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.

Second EU MDR Notified Body Designated In France

Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.


Latest Headlines
See All



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