…or, how to comply with the UK Medical Device Regulations 2019 if there is no deal?
At some point, which could be 11pm BST on Friday 12th April, or perhaps a later date if the UK PM obtains her "short" extension, the UK could still fall over the Brexit "cliff edge" and lands with a bump, or perhaps a boom, of a no-deal / hard Brexit.
In anticipation of such an event, what should medical device manufacturers do? For the purposes of this post, I will assume that manufacturers have already taken the necessary steps to be able to continue to sell their devices in the EU27, for which see: URGENT: Actions to take before Brexit for medical device manufacturers.
What about placing medical devices on the market in the UK after a hard Brexit?
In the event of a hard Brexit, the snappily named Medical Devices (Amendment etc) (EU Exit) Regulations 2019 will come into force. These amend the UK's current Medical Devices Regulations 2002. They have two main purposes:
- allow for the eventual application of regulations which look remarkably like the MDR and IVDR (and apply with the same timings); and
- deal with the UK's position as a country that is no longer part of the EU27 and therefore of its regulatory regime under the Directives.
For anyone who has not read, or who is struggling with the 230 pages of the 2019 draft Regulations, here is a summary of what you need to do to continue to lawfully continue to place on the UK market medical devices which are currently compliant with EU law. These apply whether your current certificate, if any, has been issued by a EU27 notified body, or one from the UK:
- Immediately on Exit Day: business as usual: no changes to labelling or actions required on day 1 of Brexit.
- 4, 8 or 12 months after Exit Day (timing class dependent, see image below):
- appoint a UK Responsible Person
- register economic operators and all devices being placed on the market in the UK
- From 26 May 2020 for general medical devices, and 26 May 2022 for in vitro medical devices, add to product labels: the name and address of the person placing the device on the UK market. This can probably be by way of overstickering, but this will likely be confirmed in due course by the MHRA.
So what of the FAKE NEWS?
The fake news is the requirement to include a UK Competent Authority Mark on all medical devices being placed on the market in the UK. This is incorrect: there is no such requirement in the 2019 Regulations, or anywhere else.