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 And Symbols Standards Harmonized Under EU's IVDR

Executive Summary

The European version of the international risk management standard, EN ISO 14971:2019, may have slipped through the net this January, but the European Commission has just published five new standards harmonized under the IVD Regulation.

You may also be interested in...



EU’s Risk Management Standard Officially Recognized In Context Of The IVDR

Only one new standard has been added to the official list of standards recognized in the context of the EU IVD Regulation in the latest update. The good news is that it is arguably one of the most needed standards by the IVD industry after the medtech quality management standard, ISO 13485.

Commission Publishes Draft Implementing Regulation For Insufficiently Regulated Products

At last, common specifications for different groups of products that do not have an intended medical purpose but are covered in the scope of the EU’s Medical Device Regulation, are on the way.

Updated Version Of EN ISO 13485 Now Officially Harmonized Under MDR Along With Other Standards

The New Year has seen the official publication of a series of long-awaited new medtech standards, including some that are critical to large swathes of the medical device industry.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT144923

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