In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Just Three UK Medical Device Notified Bodies Left As LRQA Pulls Out

Executive Summary

Medtech companies that have been loyal to LRQA could find themselves at a serious competitive disadvantage as the organization pulls out as a notified body for medical devices and IVDs, putting the whole medtech regulatory system under increased stress.

You may also be interested in...



'Burn Them Out, Turn Them Over': Add Auditor Exhaustion, 'Boutique' Approach To The List Of Notified Body Challenges

From not enough notified bodies and auditors, to a slew of new or updated international standards and regulations coming into force, the medtech industry is facing a number of NB challenges – and now they can add auditor burnout as a concern. "Because some of these notified bodies have such huge demand, they're burning people out really fast," industry expert Kim Trautman says, noting that device-makers can expect to see "boutique" notified bodies popping up over the coming decade. Also: Johnson & Johnson's regulatory director explains how the dearth of notified bodies and auditors is affecting the global medical products giant.

Did The UK Government Really Spurn EU Ventilator Procurement Support?

The UK is taking measures to increase its ventilator stock from 8,000 to some 30,000, but it will take time to make them available. Many are asking whether the government really rejected EU help, which could have brought relief sooner, because of Brexit.

UK Reveals How To Access Fast-Track Approval Of Devices During COVID-19 Outbreak

How to get non-CE-marked medical devices onto the UK market at speed

Topics

UsernamePublicRestriction

Register

MT125244

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