Medtech 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

EU Prioritizes Risk Management And Quality System Standards Now Legal Basis In Place

Executive Summary

Ensuring key standards are available for manufacturers to demonstrate compliance with the MDR and IVDR is one of the top priorities for the European Commission after the summer break.

You may also be interested in...



Medical Device Regulation Fall-Out Will Make EU Compliance Tricky For Years

Medtech companies accessing the EU market must be fully compliant with the new Medical Device Regulation by 26 May 2024 – but the regulatory structure is incomplete and companies also have the ongoing pandemic to contend with.

EN ISO 13485 Linked To MDR and IVDR At Last

Nearly four months after the full application date of the EU’s Medical Device Regulation, the EU standards bodies have updated the most critical medtech standard to align it with the new EU medtech regulations.

EU Regulatory Round-Up, January 2023: Cautious Optimism As New MDR Proposal Unveiled

All eyes were on the European Commission in January as it edged closer to adopting new legislation that will see the Medical Device Regulation transition deadlines extended.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT144336

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