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

Why The New EU Medtech Regulations Have Caused Chaos And Concern For Combination Products

Executive Summary

The EU could be on the point of serious disruption to the regulation of products that combine devices and drugs. The extent of EMA involvement is creating nervousness in the devices industry. In what direction are EU rules headed?

You may also be interested in...



Why The European Pharmaceutical Strategy Matters So Much For The Devices Sector

The regulation of medicines and medical devices have long worked along parallel, but very different, lines. Now there is increasing pressure for them to also be jointly improved to support innovation.

Time To Comment On ‘Bold New Regulatory Regime’ For UK

Unconstrained by having to compromise with other countries’ regulatory approaches, the UK is now seeking views on its proposal for a pioneering and “bold new regulatory regime” for medtech products.

How The MDR Is Making The EU Competitively Backward

Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with capacity and new processes, are creating a clunky, slow and expensive EU regulatory system that could damage EU industry, delegates heard at the RAPS Convergence meeting earlier this week.

Topics

UsernamePublicRestriction

Register

MT144439

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