Where an adverse event (AE), product complaint (PC) or special reporting situation (SRS) is raised during market research it is subject to the normal reporting rules

Refer to the Guidelines - section E6.2: Collecting adverse event (AE) reports

And for full details see the joint ABPI/BHBIA Guidance notes on collecting adverse events, product complaints and special reporting situations during market research.

The Guidance notes were updated in February 2021 to include medical devices. The same requirements for AE/PC/SRS reporting that apply to medicinal products have been extended to medical devices.