Clinical evaluation is conducted throughout the life cycle of a medical device as an ongoing process. To gain market access, it is first performed during the development of a medical device for an initial CE mark and then updated regularly as per mandated standards.
When a clinical evaluation is undertaken for the development a new medical device – premarket research and development processes guide the evaluation process. Manufacturers conduct gap searches to identify any gaps in the current data, determine if equivalence is to be claimed, and to define the requirements for demonstrating safety and performance of the device. Therefore, as the initial clinical evaluation identifies the questions to be answered by a clinical investigation, the clinical evaluation process should generally commence in advance of any clinical investigation.
Whereas, when a clinical evaluation is undertaken for an initial CE mark and subsequent placement of the device on the market, the purpose is to identify aspects that need to be addressed systematically during post-market surveillance (PMS), e.g., estimating the requirement of a post market clinical follow-up (PMCF) study. These aspects include an estimation of the residual risks and uncertainties, or any unanswered questions (such as rare complications, uncertainties regarding long-term performance, safety under wide-spread use). Additionally, the evaluation process aims at documenting sufficient clinical evidence to demonstrate conformity with the GSPRs covering clinical performance and clinical safety.