08 April 2021
As part of the Association’s ongoing engagement with MHRA in relation to the UK Responsible Person (UKRP), the regulator has clarified the underlying legal liability associated with the role.
The MHRA has clarified that, following the end of the Brexit Transition Period and the entry into force of the new UK regulatory framework, the following provision of the UK Medical Devices Regulations 2002 (SI 2002, No 618) (as amended) applies in relation to UKRPs:
Part VII, regulation 60(3)
60.— [ Status of UK responsible person ] …
(3) A UK responsible person—
(a) may be proceeded against as a person placing the device on the market for the purposes of these regulations;
(b) in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market.
We are continuing to liaise with MHRA’s Devices Regulatory Policy and legal teams regarding the implications of this legal liability for companies acting as UKRPs, including the extent to which UKRPs will be expected to review a device’s technical documentation. The MHRA has agreed to review and amend its online guidance in this area if necessary.