Regulatory Authority
Medicines and Healthcare products Regulatory Agency (MHRA)
Classification
Class I, Class IIa, Class IIb, Class III.
Quality system
Compliant with technical norm 13485:2016
Any Medical Device, IVD or custom device must be registered at the MHRA before being placed on the market in the United Kingdom. According to the risk class of the device, different grace periods are provided to allow compliance with the new registration process:
- 4 months (until 30 April 2021): active implantable Medical Devices, Class III Medical Devices, Class IIb implantable Medical Devices, IVD List A products;
- 8 months (until 31 August 2021): Class IIb non-implantable Medical Devices, Class IIa Medical Devices, IVD List B products, self-test IVDs;
- 12 months (until 31 December 2021): Class I devices, general IVDs.
If the registration is not made within these dates, it is not possible to legally introduce the device on the UK market.
Applicant
UK Responsible Person (UKRP).
Labelling and documentation language
The CE marking shall be used and recognised until 30 June 2023, as well as CE mark certificated issued by Notified Bodies established in the European Economic Area (EEA).
Moreover, from 1 July 2023, in order to place a device on the UK market, it will also be necessary to meet the requirements for affixing the UKCA mark on the device.
Useful information
The Medicines and Healthcare products Regulatory Agency (MHRA) website is constantly updated.
