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

Executive Summary

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.

You may also be interested in...



Compliance Corner: Being MDSAP-Ready Helpful While FDA Foreign Inspections Paused, Expert Says

King & Spalding’s Eric Henry urges manufacturers – particularly ones with facilities outside the US – to be prepared for a virtual audit under the Medical Device Single Audit Program. He explains how.

‘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. 

Manufacturers That Are Nearly MDR-Ready May Lose Their Advantage Unless Audits Can Take Place Virtually

Industry is urgently seeking certainty over EU virtual notified body audits, fearing that companies now at the front of the MDR line might be sent to the back and have to reapply under the existing directives.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

MT126564

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