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

EU Notified Body Association Takes Steps To Allay EC’s Virtual Audit Fears

Executive Summary

The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.

You may also be interested in...



EU Notified Bodies Advise Manufacturers To Think Hard About Regulatory Strategy Timings

Waiting until the grace period expires before making a product application under the EU MDR or IVDR is a gambit that could easily misfire, TEAM-NB warns.

Commission Allows Virtual MDR and IVDR Audits – Under Strict Conditions

Notified bodies may temporarily deviate, where fully justified, from the MDR and IVDR rules for notified body audits of manufacturers’ QMS to take place on site. Vital audits can now go ahead.

EU Regulatory Round-Up, January 2023: Cautious Optimism As New MDR Proposal Unveiled

All eyes were on the European Commission in January as it edged closer to adopting new legislation that will see the Medical Device Regulation transition deadlines extended.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT143346

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