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

Commission Publishes Implementing Regulation That Acts As Basic Starter Manual For Eudamed

Executive Summary

The European Commission has published an Implementing Regulation explaining some of the fundamental practices that need to be carried out by different actors from the beginning for Eudamed to operate successfully.

You may also be interested in...



Are Latest Challenges Threatening To Push Eudamed Launch Date Into 2023?

While nothing is official yet, it seems that the EU is likely to struggle to have two of the six Eudamed modules ready on time. Might this mean a further delay, or will the system be officially launched without them? 

EU Advises Third Country COVID-19 Test Manufacturers To Contact Notified Bodies Now

Manufacturers of COVID-19 tests may now have longer to comply with the IVD Regulation. But those from third countries need to be aware of the deadlines and hurdles ahead and act now.

EU IVDR Amending Regulation Published And Staggered Grace Periods Now Official

The text amending the IVD Regulation, taking the pressure of the entire sector, has now been officially published. But clarification is needed regarding timelines for compliance for in-house IVDs.

Topics

UsernamePublicRestriction

Register

MT144778

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