Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Executive Summary

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.

You may also be interested in...



Global Medtech Guidance Tracker: September 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Find Resources To Designate IVDR Notified Bodies, Commission Tells Member States

There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussion at the Council of the EU have now added to this drive.

Rob Ten Hoedt Reelected Chairman Of MedTech Europe Board

Seven changes have been made to the MedTech Europe board while the tenure of the current chair, a familiar face and well experienced in the role, has been extended for two years.

Topics

UsernamePublicRestriction

Register

MT144537

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