The revised guidance MEDDEV 2.7/1 rev 4 reveals a course of changes to a more prescriptive and demanding set of expectations. A sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient evidence to demonstrate conformity with relevant essential requirements for performance and safety is very critical. The demonstration of “equivalence” between subject device and predicate is much stricter now and may lead to requirement of generating more clinical data with larger patient populations. The importance of an overall evaluation of the device needs to be emphasized with particular focus on ensuring that clinical data are evaluated in a systematic and objective way, that the benefit/risk profile is acceptable and any knowledge gaps are identified and addressed. Considering the importance & requirement of clinical evaluation for CER writing and updating, this webinar is planned to focus on the following aspects.
- 5 stages of Clinical evaluation
- New Requirements for justifying Equivalence
- PMS & PMCF
- Qualifications of the Evaluators