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

Latest EU Clinical investigation Guidance Considers ‘Substantial Modification’ Definition

Executive Summary

In some cases, a “substantial” change to a clinical investigation will mean having to start anew. Industry is in urgent need of clarification of the term. But does latest EU guidance help sufficiently?

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

MT143857

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