HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

European Self-Care Industry Welcomes Medical Devices Regulation Delay

Executive Summary

The AESGP welcomes the European Commission's decision to delay the EU Medical Devices Regulation compliance deadline by one-year, and calls for a rapid increase in the number of notified bodies and the development of guidance documents.

You may also be interested in...



Self-Care Devices Will Need New UKCA Mark Post-Brexit

Self-care medical devices sold in Great Britain post-Brexit will require a new UKCA certification mark, which importantly will not be recognized in the EU, EEA or Northern Ireland, requiring manufacturers to navigate two separate regulatory systems. 

Podcast: COVID-19's Impact On The European Consumer Health Market

As the coronavirus continues to spread across Europe, HBW Insight editors Tom Gallen and David Ridley discuss how the pandemic is impacting the region's consumer healthcare market. 

EU Regulatory Round-Up: RWE Platform Proposed, Brexit Transition Update, EPI Principles Published

The latest EU regulatory developments - EMA and HMA are looking to build an EU-wide real-world data platform; EU OTC firms can operate as normal in the UK until the end of the year; EMA, HMA and the EC have published key principles on how to develop and use electronic product information for medicines marketed within the EU.  

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS150004

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