UK Medical Device Regulations

On 1st January 2021 the UK will implement new medical device regulations.

Upon the UK leaving the European Union on 1st January 2021, medical devices will be regulated under the sole responsibility of the UK Medicines and Healthcare products Regulatory Agency (MHRA).

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

Additionally, 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 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.

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