Already the directive on clinical evaluations of June 2016 MEDDEV 2.7/1 rev. 4 increased significantly the requirements for clinical evaluations of medical devices, which means a considerable additional effort for medical device companies. The MEDDEV 2.7/1 rev. 4 can be seen here as a harbinger for the Medical Device Regulation MDR. The requirements for clinical evaluation are already defined here. The difference is that the Medical Device Regulation makes them legally binding.
A central aspect of the requirements is the presentation of adequate clinical data. In many cases, the Notified Bodies now request to generate own clinical data. Since this cannot been practiced overnight, this aspect currently represents one of the biggest challenges with clinical evaluations. The clinical evaluation is a key document in CE certification. Its importance will increase further under the MDR.
Review your clinical evaluations critical soon enough that you have the chance to act in time. We support you:
- Review of your current clinical evaluations.
- Critical review of the underlying clinical data.
- Proposals for obtaining clinical data up to the preparation of a post-market clinical follow-up plan (PMCF).
- Research and appraisal of clinical data on a literature route up to the preparation of a clinical evaluation plan.
- Preparation or revision of your clinical evaluations.
Documentation in English language, optionally in German language.