The UK has taken the critical step of asking Parliament to approve legislation to future-proof the regulation of medical devices in event of a no-deal Brexit. The proposed new legislation also introduces the new EU requirements contained in the Medical Device and IVD Regulations into national law.
It reflects the UK’s stated intention to continue to follow EU medical device rules for the time being until an announcement is made otherwise in the event of a no-deal Brexit, or in the framework of a Brexit with an agreed withdrawal period.
For medical devices, the key arrangements include: for a time-limited period, devices that have a CE mark from a notified body based in the UK or an EU country will continue to be recognized by UK law and allowed to be placed on the UK market; and the expansion of the MHRA’s registration system to all classes of medical device.
The proposed amendment can be downloaded here: http://www.legislation.gov.uk/ukdsi/2019/9780111179260/contents