The MHRA’s medical device webpage (updated 4th November) provides information on how to place a device on the GB, Northern Ireland (NI) and EU markets following the end of the transition period. It has been updated with a link to new UKNI guidance.
When placing a device on the market from January onwards, NI will align with all relevant EU rules. Consequently, in addition to the CE marking, device manufacturers will also need to apply for UKNI marking if they choose to use a UK Notified Body for mandatory third-party conformity assessment.
In summary, UKNI marking is required:
- when placing certain medical devices on the NI market after the end of the transition period; and
- the device requires mandatory third-party conformity assessment; and
- a UK body is used to carry out those conformity assessments after the transition period
Another update provides clarification on the grace period.
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 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
Further information on the general arrangements for placing goods on the Northern Ireland market, see also the guidance on placing manufactured goods on the market in Northern Ireland.
For further information on general requirements across the UK, see marking, labelling and marketing standards from 1 January 2021.