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

IVDR Notified Body Pulls Applications As The EU System Struggles To Cope

Executive Summary

European Commission figures have already suggested IVD testing capacity could be woefully short of demand. Now one notified body applicant is dropping out. What are the implications?

You may also be interested in...



Consultants Over Notified Bodies? Manufacturers Losing Vital Resources With High Demand For EU Regulatory Experts

NSF Ireland recently withdrew its application for notified body status under the IVDR and MDR. Its reason? Demand among manufacturers for consultancy outweighs the need for another notified body. But aren't more notified body resources needed too?

Second MDR Polish Notified Body Designation Means EU Total Reaches 33

New designations of notified bodies under the Medical Device Regulation continue to trickle through slowly. The latest brings the EU’s total to 33, still way short of the previous 80 or so under the Medical Devices Directive.

European Commission Reshuffle Sees New Innovation Focus For Devices

Changes have occurred in the management focus within the European Commission’s directorate responsible for medtech but not within the devices leadership; familiar faces remain.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT123326

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