For the MHRA to carry out its market surveillance activities, it is necessary for economic operators (Medical Device Manufacturer or UKRP- UK Responsible Person) to register themselves, their products, applicable certificates and clinical investigations or performance studies. The medical device registration requirements apply to all devices marketed in the UK, whether newly manufactured or refurbished, this includes custom made devices and systems or procedure packages that contain at least one device and include IVDs for device evaluation performance.
UK based medical device manufacturers can complete the registration themselves, but manufacturers outside of the UK must have a designated UK Responsible Person (UK Authorized representative) based in the UK to register for them. The UKRP must register the manufacturer, importer, and their devices.
Furthermore, medical device manufacturers based UK and Northern Ireland based authorized representatives are required to keep their current records of Class I devices, custom made devices and general IVDs. This implies that any new device must be registered before it can be marketed.
For non-UK manufacturers that were already supplying its devices to the UK market, the following deadlines for registration apply:
- Active implantable devices, Class III devices, Class IIb implantable devices, and IVDs listed on List A must be registered before May 1, 2021;
- Class IIb non-implantable devices, Class IIa devices, IVDs listed on List B, and self-test IVDs must be registered before September 1, 2021;
- All other devices (Class I devices and general IVDs) must be registered before January 1, 2022.
These are also deadlines for registration of the medical device manufacturer and its UK authorized representative. Deadlines are not specified for importers, but they must register as soon as possible, as importers must register before placing their devices on the market in the UK.
However, MDR 2017/745 and IVDR 2017/745 will be fully implemented in EU Member States from May 21, 2021 and May 21, 2022 respectively. As these regulations did not come into force during the transition period, their provisions will NOT be automatically implemented and enforced in Great Britain. The UK MDR 2002, on the other hand, will continue to have effect in Great Britain after the transition period.
When conformity assessment by a third party is required, it is necessary to apply to a UK Approved Notified Body. The MHRA designates the UK Approved Notified Bodies, so that the ability to conduct conformity assessments regarding the requirements for UKCA marking.