Introduction The introduction may contain a brief statement placing the clinical investigation in the context of the development of the investigational medical device and relating the critical features of the clinical investigation (e.g. objectives and hypotheses, target population, treatment and follow-up duration) to that development. 6. Investigational medical device and methods 6.1 Investi ...

Risks and benefits of the investigational medical device and clinical investigation (a) Anticipated clinical benefits. (b) Anticipated adverse device effects. (c) Residual risks associated with investigational medical device, as identified in the risk analysis report. (d) Risks associated with participation in the clinical investigation. (e) Possible interactions with concomitant medical treatment ...