Medical Device Registration in UK

Please see the steps below for Medical Device Registration in UK (excluding Northern Ireland). We could also term this market as Great Britain. UK consists of Great Britain and Northern Ireland.

1. Comply to CE MDD/ MDR/ IVDD/ IVDR which is in line with UK MDR 2002 for medical device/ In vitro diagnostic device (Both technical file and Quality Management System)
2. if you are a manufacturer based outside the UK and wishes 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.
3. Manufacturers of Class I medical devices and general IVDs can self-declare their conformity against the EU MDD or EU IVDD as transposed by the UK MDR 2002 (as amended), before affixing a UKCA mark and placing the device on the Great Britain market. Other classes need to be certify by a Notified Body or UK Approved Body.
4. Please note that Class I medical devices that are sterile or have a measuring function require approval from a UK Approved Body in order to be affixed with the UKCA mark and placed on the Great Britain market
5. 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 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
6. CE marking will continue to be recognised in Great Britain until 30 June 2023
7. The name and address of the UK Responsible Person, where applicable, must be included on product labelling where the UKCA mark has been affixed. UK Responsible Person details do not need to be included on labelling for CE marked devices.
8. The importer’s name and address does not need to be present on the label unless the importer or distributor are acting as the UK Responsible Person for the purposes of the UKCA mark.
9. Manufacturers can use the UKCA mark on a voluntary basis until 30 June 2023. From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market.
10. Once a medical device has been placed on the UK market, the manufacturer is required to submit vigilance reports to the MHRA when certain incidents occur in the UK that involve their device.