Surprise As UK Notified Bodies Lose Major Part Of Their UK Role In Devices From March 29

11 Feb 2019

There is now even more urgency for medtech companies, including small firms, to employ the services of EU27 notified bodies – with UK notified bodies set to have their conformity assessment roles temporarily withdrawn if the UK leaves on March 29 without a deal.

Brexit written on cover of book on blue background.. Mature woman being focused and hooked by book. - Image

If there is no Brexit deal as of March 29, companies making any new devices that need a notified body assessment to be placed on the UK market will need to go through a conformity assessment with an EU27 notified body ̶ and NOT through a UK notified body ̶ before having the CE mark placed on them.

That is the latest position from the UK medtech regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), as explained...