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
UsernamePublicRestriction

European Regulatory Roundup, April 2021: All Cylinders Firing On MDR And IVDR Front

Executive Summary

The EU MDR date of application is three weeks away; while this date may look more tenable than before, deadlines in 2022 and 2024 leave the medtech industry, and especially its IVD sector, wondering how to stop products being lost from the market.

You may also be interested in...



How The EU Artificial Intelligence Regulation Will Overlap With Medical Device Regulations

Artificial intelligence is incorporated into medical devices and IVDs with increasing frequency. But it is only now that the EU is working on how that process will be regulated.

EU Extends Scope Of Electronic IFU To Medical Device Software In First Update In Nine Years

For the first time in nine years, the European Commission looking at the extent to which IFU for medical devices may be made available electronically.

First Version Of Vital Eudamed Communication Support Tool Released

Stakeholders have access to the first version of the European Medical Device Nomenclature, an aid to identifying the precise type of device being referred to. And their views on the naming system are being sought too.

Topics

UsernamePublicRestriction

Register

MT143873

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