BREXIT Impact and related changes

As everyone knows there has been significant changes, as of 1st January 2021 to the way we do business in the UK with Europe, non-more so than in the medical device sector.

I am sure everyone within the field is fully aware of the changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain. Actually 95% of the people I have spoken with in a recent survey, said they were prepared the best they can and were awaiting the final clarification. Despite this, here are the summarised changes to key requirements for placing devices on the Great Britain market:

• CE marking will continue to be recognised in Great Britain until 30 June 2023

• Certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023

• the EU no longer recognises UK Notified Bodies

• UK Notified Bodies are not able to issue CE certificates (other than for the purposes of the “CE UKNI” marking, which is valid in Northern Ireland) - and have become UK Approved Bodies

• A new route to market and product marking is available for manufacturers wishing to place a device on the Great Britain market

• Since 1 January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Great Britain market need to be registered with the MHRA. There is a grace period for registering:

  • Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered from 1 May 2021

  • Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 1 September 2021

  • Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from 1 January 2022

• Manufacturers of Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country manufacturers with Northern Ireland-based Authorised Representatives) must continue to register their devices from 1 January 2021 on the same basis as they do now rather than in line with the above dates

• if you are a manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person who will take responsibility for the product in Great Britain

These facts have been taken from the latest MHRA release on the 31st December. https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk