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

Commission Publishes Draft Implementing Regulation For Insufficiently Regulated Products

Executive Summary

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.

You may also be interested in...



EN ISO 13485 And Symbols Standards Harmonized Under EU's IVDR

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.

MDR Amendment Proposal Likely To Be Adopted In Two Weeks’ Time

Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent. It looks like the EU is keeping its foot on the accelerator to adopt its latest proposal despite concerns raised about the text.

Moves For Go Ahead For MDR Proposal To Be Discussed At European Parliament

The European Commission’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT144961

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