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

IVD Companies Brace For EU Regulatory Changes

Executive Summary

The proposed EU In Vitro Diagnostics Regulation will introduce a tougher system of regulation that will bring increased intervention of notified bodies into the compliance pathway. Companies selling IVDs into the EU market are beginning to factor in rising costs and other challenges before it takes effect.

You may also be interested in...



EU Designates 6th German Notified Body Under MDR As German/Italian Divide Grows

The latest EU designation means Germany now has six notified bodies under the MDR and Italy only one.

EU Guidance Explains How And When MDSAP Audits Can Offer Auditing Shortcuts

This is the busiest time in the history of notified bodies as they try to process all manufacturers under the EU Medical Device Regulation (MDR). Making use of MDSAP audits is one way to cut down on work but is not always an option. The EU’s latest guidance explains the detail.

UK Shares How Its Medtech Regs Already Diverge From The EU: COVID-19 Marks The Start

The MHRA has updated its guidance on regulatory flexibilities for medical devices and medicinal products resulting from COVID-19 to highlight how its approach differs from the EU.

Topics

UsernamePublicRestriction

Register

SC141576

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