UK – MHRA Updates Guidance on Clinical Investigations of Devices

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday published the fifth version of a guidance document meant to help manufacturers provide the necessary clinical data to CE mark a device.

This latest update focuses on the practical decisions behind when a clinical investigation is required. This section offers four questions that a manufacturer needs to work through in order to decide if such an investigation is required, including: “What are the essential requirements relevant to the device in question with which compliance must be demonstrated?” and “Are clinical data required to demonstrate compliance? If so, do the clinical data already exist on the device in question (published or unpublished) or by analogy with published data generated in respect of an equivalent device.”…