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

Just Four Items Remain On European Commission’s High Priority IVDR List

Executive Summary

The IVD Regulation has applied in the EU since 26 May this year. This year has seen a rapid output of IVDR guidance and other implementation documents. Soon the list will be completed.

You may also be interested in...



Crucial Council Of EU Debate On Medical Device Regulation Crisis Countdown

The Council of EU’s agenda for the critical upcoming health council meeting confirms position of EU Medical Device Regulation in day’s running, along with other key health issues.

Reclassification Of Active Annex XVI Products Now Official

Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.

European Regulatory Roundup, November 2022: EU MDR Situation Now Critical

Damage limitation action is expected imminently to try and stem the flow of medtech products being taken off the EU market. And it cannot come quickly enough as evidence continues to mount of the negative fall-out resulting from the way the EU’s new medical device regulations have been, and are being, implemented.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT146033

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