After years of uncertainty following Brexit and extensive discussions across the medical device industry, the wait is finally over. The UK Government has confirmed that medical devices and in vitro diagnostic devices certified under EU MDR 2017/745 and EU IVDR 2017/746 will be recognized in Great Britain indefinitely.
This long-awaited decision provides manufacturers with much-needed regulatory certainty and removes concerns about a future requirement for separate UKCA certification for products already compliant with the EU regulations.
The UK Government has confirmed that, subject to parliamentary approval…
- CE marking of devices compliant with EU MDR 2017/745 and EU IVDR 2017/746 will be recognized indefinitely.
- CE marking of MDD “legacy” devices will be accepted until December 31, 2028 (so far June 30, 2028) so it will be aligned with the EU.
- Manufacturers holding valid CE certificates under EU MDR or EU IVDR can continue placing their devices on the Great Britain market without the need for an additional UK conformity assessment route.
- Planning the schedule and conformity deadlines for legacy devices can now be aligned across the EU and the UK.
- Continued access to the Great Britain market using existing EU MDR and IVDR CE certificates.
- Reduced regulatory burden and costs by avoiding duplicative conformity assessment processes.
- Greater regulatory certainty for long-term product planning and market access strategies.
- Improved availability of medical technologies for healthcare providers and patients across Great Britain.
- Appointment of a UK Responsible Person (UKRP) where applicable.
- MHRA registration of devices.
- Compliance with UK post-market surveillance and vigilance requirements.
For manufacturers already operating under MDR and IVDR, this announcement provides a clear and efficient pathway to maintain access to the Great Britain market for years to come under the CE marking.
