The UK has left the EU, and the transition period after Brexit comes to an end this year. The MHRA, the UK’s medical regulatory and supervisory authority, has its hands full informing inquiries from manufacturers and distributors of medical devices about the upcoming regulations. A guidance document was published specifically for this purpose in early September. BEO BERLIN will keep you informed of any changes.
From January 1st, 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain:
- CE marking will continue to be recognised in Great Britain until June, 30th 2023.
- Certificates issued by EU-recognised Notified Bodies will continue to be valid for the British market until June, 30th 2023.
- After the transition period, the EU will no longer recognise UK Notified Bodies.
- UK Notified Bodies will not be able to issue CE certificates (other than for the purposes of the “CE UKNI” marking, which will be valid in Northern Ireland) – and will become UK Approved Bodies from January 1st, 2021.
- A new route to market and product marking will be available for manufacturers wishing to place a device on the British market from January 1st, 2021.
- From 1 January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
- Class III and Class IIb implantable, and all active implantable medical devices and IVD List A products must be registered from May 1st, 2021.
- Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from September 1st, 2021.
- Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from January 1st, 2022.
- Manufacturers of Class I devices, custom-made devices and general IVDs that are currently required to register their devices with the MHRA must continue to register their devices from January 1st, 2021 on the same basis as they do now until the new registration requirements start to apply to those devices
- If you are a manufacturer based outside the UK and wish to place a device on the British market, you will need to appoint a UK Responsible Person who will take responsibility for the product in the UK.