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

Guidance Needed To Explain Scope Of MDR’s Confusing Clinical Investigations Clause

Executive Summary

Article 61(5) of the EU’s Medical Device Regulation gives certain manufacturers an exemption from having to perform clinical investigations by demonstrating equivalence to other companies’ products. But to whom does it apply and who could actually make use of it? Dr. Maria Donawa explains why clarification is urgently needed.

You may also be interested in...



Second MDR Polish Notified Body Designation Means EU Total Reaches 33

New designations of notified bodies under the Medical Device Regulation continue to trickle through slowly. The latest brings the EU’s total to 33, still way short of the previous 80 or so under the Medical Devices Directive.

European Commission Reshuffle Sees New Innovation Focus For Devices

Changes have occurred in the management focus within the European Commission’s directorate responsible for medtech but not within the devices leadership; familiar faces remain.

European Regulatory Roundup, August 2022: Stakeholders Start Taking Radical Decisions

The regulation of clinical evidence and cybersecurity as well as lack of auditor availability were among the topics causing most concern to the medtech industry in September. But obstacles to the smooth implementation of the Medical Device and IVD Regulations persist and some actors are taking matters into their own hands.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT125805

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