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

Manufacturers Of Annex XVI Non-Clinical Devices Get Extra Time

Executive Summary

Following the timelines laid out in the European Commission’s new implementing regulation for Annex XVI non-clinical devices is not for the faint-hearted. It involves multiple cross-referencing between several commission regulations. Medtech Insight clarifies the situation.

You may also be interested in...



First Dermal Filler CE-marked Under Annex XVI Of The EU's Medical Device Regulation

Austrian company Croma-Pharma is the trailblazer with its newly certified dermal filler.

Commission Text Clarifying Timelines For Annex XVI Devices May Leave Companies Dazed

The revised timelines around products generally used for aesthetic purposes, a small subset of products falling under the Medical Device Regulation, create their own microsphere of complexity.

MDR Amending Regulation Officially Published And Already In Force

The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT148050

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