Question to the Department of Health and Social Care:

To ask Her Majesty's Government whether the NHSX COVID-19 contact tracing application is considered to be a Grade 1 medical device in law, and if so, what rules must trials of such a product follow.

The NHSX COVID-19 contract tracing application is considered Class IIa under the Medical Devices Regulations (2002).

The legal requirements relating to clinical investigations are set out in the Medical Devices Regulations 2002 (section 16 and section 29) and the Medical Devices Directive (Annexes VIII and X).

A clinical investigation of a non-CE-marked device must be designed to establish that the performance claimed by the manufacturer can be adequately demonstrated, and that the device is judged to be safe to use on patients taking into account any risks associated with the use of the device when weighed against the expected benefits.

The Medicines and Healthcare products Regulatory Agency reviewed an application made by NHSX and authorised the supply of the non-CE-marked NHSX COVID-19 contact tracing app for a pilot on the Isle of Wight in the interests of the protection of public health under Regulation 12(5) of the Medical Devices Regulations 2002.