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 IVDR Amending Regulation Published And Staggered Grace Periods Now Official

Executive Summary

The text amending the IVD Regulation, taking the pressure of the entire sector, has now been officially published. But clarification is needed regarding timelines for compliance for in-house IVDs.

You may also be interested in...



No MRA Means Switzerland’s Seamless IVDs Trade With The EU Is At An End

The EU’s full implementation of the In Vitro Diagnostic Regulation on 26 May has put the Swiss IVD industry on a "third country" footing with the EU, as happened in 2021 for medical devices. The two parties’ mutual recognition agreement for all medtech products has ceased to apply. A renewed MRA is not likely for several years.

Commission Set To Give IVD Industry Extra Time To Comply With Class D Common Specifications

The European Commission has published the first draft Implementing Regulation for common specifications in the context of the IVDR. There is an unexpected two-year gap until its requirements will be mandatory.

Time To Address Root Causes Of IVDR Notified Body Capacity Shortfall, Commission Says

The European Commission has injected an increased sense of urgency into its updated IVDR implementation plan and is creating a feedback loop to help direct resources where most needed.

Topics

Latest News
UsernamePublicRestriction

Register

MT144993

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