Module 17 2024

05/12/2024

Chapter 7: Clinical Investigations

General requirements regarding clinical investigations (general medical devices) The new regulations will set out that clinical investigations conducted for one or more of the following purposes shall be designed, authorized, conducted, recorded and reported in accordance with the UK medical devices regulations: a. To establish and verify that, under normal conditions of use the medical device achieves the performance intended by its manufacturer b. To establish and verify the clinical benefits of a medical device as specified by its manufacturer c. To establish and verify the clinical safety of the medical device and to determine any undesirable side-effects, under normal conditions of use of the medical device, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the medical device.

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Chapter 7: Clinical Investigations

Non-UK based sponsors of clinical investigations and performance studies will be required to appoint a UK-based legal representative. This legal representative is responsible for ensuring compliance with the sponsor’s obligations and acts as the addressee for all communications with the sponsor. The regulations will detail the sponsor’s obligations. Minimum requirements for the clinical investigation report are also documented in the regulations The clinical investigation report will also require to be accompanied by a publicly accessible lay person summary. The MHRA will clarify in the regulations, the time frame for publication. Further guidance and templates will also be developed for the clinical investigation report.

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