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
UsernamePublicRestriction

Latest MDR Guidances: Vital Clinical Evidence Documents And Timely Ventilator Requirements

Executive Summary

Clinical evidence requirements are much tighter under the EU Medical Device Regulation. Now there is help in addressing these requirements as April sees the publication of a flood of seven guidance documents in total intended to help manufacturers comply with the MDR.

You may also be interested in...



‘Months Of Activity’ Lost By Notified Bodies: New EU Measures May Be Needed

The European Commission has admitted that MDR implementation has been severely compromised by COVID-19, and potential delays in notified body conformity assessment of products must be addressed to avoid device shortages for patients. 

Guidance Clarifies EU Position On Alternatives To Notified Body On-Site Audits

Virtual notified body audits of medtech manufacturers are already taking place through necessity. Now there is guidance concerning if, when, where and how these audits should be carried out.

Notified Body Pain Points: The Challenges And Obstacles Industry Needs To Avoid

Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?

Topics

UsernamePublicRestriction

Register

OM013195

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