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

EN ISO 13485 Linked To MDR and IVDR At Last

Executive Summary

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.

You may also be interested in...



Progress In Aligning EU’s Risk Management Standard With New MDR And IVDR

The medtech sector can be hopeful now that the updated medical device risk management standard, EN ISO 14971, will be officially published soon so it can be used to demonstrate compliance with the new EU medical device regulations.

EN ISO 13485 and EN ISO 14971: Next Wave Of EU Standards Now Due ‘By December’

The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.

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

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.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT144451

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