PARLIAMENTARY WRITTEN QUESTION
Diagnosis: Regulation (1 June 2022)

The Medicine and Healthcare products Regulatory Agency (MHRA) held a public consultation in autumn 2021 on the future regulatory framework for medical devices. The MHRA consulted on amendments to the in vitro diagnostic (IVD) regulations focusing on improving patient safety and strengthening regulatory requirements. This included potential reforms to increase the level of scrutiny applied to IVD devices. The MHRA is currently finalising its response to the consultation and further details on new regulatory requirements and appropriate transitional arrangements will be made available in due course.

The Government intends to enable a proportionate fast-track route for IVDs should future health threats emerge, while maintaining quality and performance.