We have previously written about the Medical Device Regulations which came into force across the EU on the 26 May 2021 (following a year’s delay as a result of COVID-19) - see here and here. The In Vitro Device Regulations will come into force a year later - on 26 May 2022.
The UK government has confirmed that because these regulations were made during the Brexit transition period they will not now be coming into force in Great Britain (GB). In GB businesses will therefore need to continue to comply with the old Medical Devices Regulation 2002 (as amended). The government has suggested that new law in this area will be considered in due course.
So as in a number of areas we are seeing early signs of the divergence of GB and EU laws following Brexit.
Many businesses in GB might in principle welcome a lighter touch approach to regulation. However, the current position is far from straightforward, with those selling across Europe now having to adjust to Brexit and the divergence of GB and EU law, as well as updates to the law in the EU. Within the UK, businesses have to grapple with the different legal regimes applying in GB and Northern Ireland. Some key elements of the current timetable for businesses in GB include:
- Where applicable, registering medical devices with the MHRA this year, with different "grace periods" depending on the class of the medical device
- Where applicable, registering separately with EU notified bodies
- Appointing UK Responsible Persons/Authorised Representatives in the EU if not established there
- Transitioning from the use of CE to UK Conformity Assessed (UKCA) marking, by June 2023 at the latest
Given that many businesses were waiting to see what the outcome of UK-EU negotiations would be before taking action, it is possible that many businesses will struggle, at least in the short term, to manage these regulatory changes. The coincidence of Brexit and the COVID-19 pandemic has however clouded things. It will be interesting to see what the compliance and enforcement landscape looks like in practice once the mud settles.
Gustaf Duhs