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

European Commission Expects Eudamed To Be Fully Ready By Q2 2024

Executive Summary

The European Commission has published an updated timeline for delivering the EU medical device database. Regarded as the cornerstone of the EU medical device and IVD regulations, the Eudamed database will have been delayed by four years and there are transition periods ahead.

You may also be interested in...



Why Adding A Legacy Device To Eudamed Now, Before It is Mandatory, Is A Shrewd Move

The EU MDR amending regulation does not impact Eudamed directly, but it may make medtech manufacturers reconsider when to register legacy devices in Eudamed. Richard Houlihan of EirMed explains.

Updated: New EU Templates For IVD Performance Study Sponsors, Including For Substantial Modifications

With the official launch of Eudamed still some 18 months aways, the EU has published a series of templates to help sponsors of IVD performance studies communicate with member state authorities. This piece has now been updated to reflect the availability of a new template for substantial modifications of a performance study.

Very Few Outstanding Items On European Commission’s Shrinking Rolling Plan

Most items have been ticked off the commission’s implementing plan now; but among the four items left, there is also a new proposal for an implementing regulation for Annex XVI products.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145589

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