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


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...

EU MDR Implementation Group Reinforces Historic Clinical Evidence Guidance Document Value

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.

EU Classification ‘Bible’ Published To Support Risk Class Decision-Making

The risk class of a medical device depends on its intended purpose and mode of action. But these are not always easy to determine. Now there is EU guidance to support this decision-making.

EU Proposal To Have Guidance Transition Periods “Does Not Make Sense”

A proposed position paper on time periods for notified bodies to roll out guidance documents aims to introduce greater predictability. But has the EU notified body organization gone too far with its proposals?


Latest News
See All



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