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

Regulating mHealth in the EU: Medical Devices Directive plus a new certification scheme?

This article was originally published in Clinica

Executive Summary

The European Commission has just published a 32-page summary report on the responses to the public consultation on its green paper on mobile health, which also encompasses apps that qualify as medical devices.

You may also be interested in...



EU Nomenclature Mapping Project News: Will Critical Progress Be Hampered By Tensions?

It seems to be game over for anyone who might have been hoping the European Commission would do a U-turn on its decision to use the Italian CND nomenclature as the basis for communication in Eudamed, instead of the well-established GMDN. But GMDN is strong in its resolve to remain a vital global nomenclature service.

European Commission’s Missed Deadlines And Contingency Planning: Welcome To 2020!

2020 is not getting off to a good start for manufacturers needing to comply with the EU’s new Medical Device Regulation on 26 May 2020. The European Commission’s latest document seems to confirm industry’s fears about the ability of the EU’s medtech system to be ready in time.

EU Regulatory Roundup, December 2019: A Veritable Avalanche Of Key Decisions And Documents

December 2019 was a big month for far-reaching EU medtech regulatory developments that will have a significant impact on the way and speed of implementation of the Medical Device Regulation.

Topics

UsernamePublicRestriction

Register

MT102293

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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