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


Latest Notified Body Designated Under the EU’s MDR Is A Software Specialist

Executive Summary

In the EU, notified bodies are usually designated for a wide spectrum of testing of different types of medical devices under the Medical Device Regulation. The latest organization to be named, however, is a specialist.

You may also be interested in...

EU AI Act Regulatory Overlap “Likely To Persist”: Expert Presents Solutions For Dual Conformity

Regulatory overlap with the MDR and IVDR is likely to persist in the finalized AI Act text. However thorough preparation by medtech companies and the use of regulatory sandboxes could help address the need for dual conformity, reports lawyer Elizabethann Wright. 

Second Czech Notified Body Designation Means EU MDR Now Totals 43

The European Commission has met its target of having 55 notified body listings under the Medical Device and IVD Regulations by the end of 2023. 

Medtech Further Examines Repercussions With EU On Cusp Of Adopting World-First AI Act

Medtech manufacturers and notified bodies must be prepared to allocate significant resource and build their AI expertise now the EU’s AI Act is on the cusp of being adopted.

Related Content


Latest Headlines
See All



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