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

What Next For Standards As CEN/CENELEC Reject MDR/IVDR Commission Request?

Executive Summary

The timetable for developing harmonized standards under the EU’s Medical Device Regulation was already tight, even with new 2021 MDR application date. But it now looks untenable, even for the most urgently needed standards.

You may also be interested in...



First Harmonized Standards Published For Both MDR And IVDR

After a long delay, the EU’s first harmonized standards under the MDR and IVDR are trickling through ̶ but the standards situation is still far from ideal.

EU Medtech May Have Standards Certainty Days Before MDR Applies

The EU’s Medical Device Regulation applies in just over a month’s time and the IVD Regulation in just over a year. But the standards underpinning them are way behind. Will they get the green light at last?

Medtech Standards Request Advances – But Too Late For MDR/IVDR First Wave

The medtech sector may, at last, be one step closer to ensuring standards are drafted or revised under the EU’s MDR and IVDR. But delays have already meant industry has had to adopt “Plan B.”

Related Content

Topics

UsernamePublicRestriction

Register

MT142357

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