The MHRA has published updated guidance on medical devices.
Regulating medicinal devices from 1 January 2021 (updated 21 October)
For Northern Ireland (NI), different rules will apply to those in Great Britain after the end of the transition period. For more information on the regulatory system for medical devices in Northern Ireland, please see ‘Regulation of medical devices in Northern Ireland’
From 1 January 2021 the MHRA will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
This guidance provides information on how the UK system will operate, including for:
- Certifying a device
- Conformity marking
- Registering a device with the MHRA
There will be a number of changes to how medical devices are placed on the market in Great Britain:
- The EU MDR and EU IVDR will apply in NI from 26 May 2021 and 26 May 2022 respectively.
- The CE marking will continue to be required. In addition, the UKNI marking will be required if a UK Notified Body undertakes mandatory third-party conformity assessment.
- After the transition period, certain medical devices, including in vitro diagnostic medical devices (IVDs), placed on the NI market will need to be registered with the MHRA. Class I devices and general IVDs placed on the market by NI manufacturers and Authorised Representatives based in Northern Ireland must be registered from 1 January 2021. For other device classes there will be a grace period for registering, as detailed in the webpage.
When placing devices on the NI market, GB-based manufacturers will need to appoint an EU or NI-based Authorised Representative.
Most manufacturers based outside the UK will need to have a UK Responsible Person in place from 1 January 2021 who will act as a regulatory point of contact within the UK from this point and comply with the registration requirements when these begin to apply.