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 If so, do the clinical data already exist on the device in question (published or unpublished) or by analogy with published data generated in respect of an equivalent device.”
The updated section also discusses seven considerations for manufacturers to mull over when deciding whether to run a clinical investigation for a non-CE marked device.
For instance, manufacturers should explore whether the device is an implantable or Class III device, if the firm is introducing a completely new concept, if a device incorporates materials previously untested in humans, and cases where in vitro and/or animal testing of the device cannot mimic the clinical situation.
The section also notes: “Notification to the MHRA will not be required if the medical device to be used is CE marked for the purpose under investigation.”
The updated guidance is part of a group of other documents related to notifying MHRA about a clinical investigation for a device.
Other guidance documents in the group discuss compiling a submission, fees for clinical investigations, assessment timelines and in vitro diagnostics. Other information on statistical considerations, biological safety assessments and classifications is also available.
The guidance comes as the UK prepares for its withdrawal from the EU at the end of the month.
Notify MHRA about a clinical investigation for a medical device