Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Stop The Clock: MedTech Europe Says IVDR, MDR Deadlines Won't Work

Executive Summary

Given the slow progress in implementing the new EU medtech regulations, industry group MedTech Europe is seeking urgent talks with the EU institutions and affected stakeholders to delay deadlines.

You may also be interested in...



Get On With It Now! EU Commission Tells Medtech Manufacturers What To Do And When

Industry has been speculating on what exactly the European Commission intended with the various deadlines it set in the EU Medical Device and IVD Regulations. In new documents, the Commission explains what manufacturers can do and when.

35 Notified Bodies In The Pipeline – But Heading For Catastrophe With Tight Timing?

New survey results suggest there could be a drop of about 40% in the number of EU notified bodies testing medical devices. A rough calculation points to an even bigger potential drop in the number that will be ready in time, when the Medical Device Regulation fully applies in 2020. A close look at newly available data signals the prospect for a serious bottleneck.

Who Can Use MDR's Four-Year Derogation Extension? Notified Bodies Try To Clarify

Many companies are pinning hopes on being able to use the EU Medical Device Regulation's four-year extension period for products CE marked under the current directives. But with a lack of clarity from the policymakers so far, TEAM-NB has stepped in.

Topics

UsernamePublicRestriction

Register

MT123041

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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