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

EU MDR Implementation Group Reinforces Historic Clinical Evidence Guidance Document Value

Executive Summary

Determining how to provide adequate clinical evidence for CE marking under the EU’s Medical Device Regulation can be a tricky business. But legacy device manufacturers will take comfort knowing they are familiar with some elements of the latest guidance.

You may also be interested in...



Common Specifications: An Antidote To MDR’s Clinical Evidence ‘Moveable Feast’?

Unpredictable clinical evidence expectations under the new EU medtech regulations can have a chilling effect on even the most established companies, resulting in product withdrawals. Medtech Insight asked a regulatory expert how this crisis can be avoided.

EU MDR: Notified Body Clinical Evidence Expectations Could Spell Trouble For Manufacturers

Detailed guidance documents aim to provide clarity on what constitutes “sufficient” clinical evidence under the ­new EU Medical Device Regulation. But a void remains between the MDR itself and what notified bodies expect, senior regulatory consultant Søren Underbjerg attests.

How MDR’s Clinical Investigation Rules Could Drive Some Spinal Fusion Products Out Of EU

The new EU Medical Device Regulation has introduced stricter clinical evidence requirements for many products. But is it even feasible to generate this data for certain legacy devices, such as those used in spinal fusion surgeries, and which products are likely to fall into the high-risk category?

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145800

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