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

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

Executive Summary

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?

You may also be interested in...



MDR Up-Classification Of Some Spinal Fusion Devices ‘Unwarranted’ Says Expert Group

A change in risk classification for some legacy spinal fusion devices under the new EU MDR means that certain products face stricter clinical evidence requirements, which expert group OSMA told Medtech Insight is “unnecessary” and “overly-burdensome” for manufacturers.

CAMD Says ‘Critical Appraisal’ Needed On EU MDR Capacity Bottlenecks

Yet another EU regulatory organization has stressed the need for action to address MDR capacity problems. According to CAMD, underlying factors and causes of the crisis must be identified.

Pediatric Cardiologists Told To Prepare For Critical Devices Disappearing Due To MDR

Medical devices used in pediatric heart surgeries and other products used for children and for orphan conditions may cease to be available in the EU due to the new Medical Device Regulation compounding existing market pressures, researchers have warned.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145799

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