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

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

Executive Summary

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.

You may also be interested in...



EU Notified Body MDR/IVDR Certificates Data: A Slow-Motion Car Crash

Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go until the absolute deadline for MDR compliance, the latest figures appear alarming.

EU IVDR Amending Regulation Published And Staggered Grace Periods Now Official

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.

EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency

Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145043

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