With system for clinical evaluation according to MDR
It is indispensable for manufacturers of medical devices of all risk classes:
The clinical evaluation according to MDR. In accordance with Regulation (EU) 2017 / 745 (MDR) and as part of the conformity assessment procedure, documentation is a prerequisite for successful market access and must be planned.
As part of the technical documentation, it is the basis for a safe medical device. The legal requirements are all the greater. But what exactly is the clinical evaluation for?
Above all, it is systematic proof that the medical device fulfills basic safety and performance requirements. The side effects that patients must expect and the consequences that can be excluded are also documented in the clinical evaluation. It thus serves as proof of a justifiable risk-benefit ratio.
Systematic for clinical evaluation
How do you create a clinical evaluation? Above all, the preparatory work is crucial: first, the process and the requirements for the product must be planned and a strategy for obtaining clinical data developed. You can obtain this data from studies from scientific literature research. Clinical trials are also suitable.
This process is part of the technical documentation. This means that all steps of the clinical evaluation must be planned and recorded in a report.
CEP and CER – what are they?
The Clinical Evaluation Scope & Plan (CEP) and the Clinical Evaluation Report (CER) are mandatory documents of the technical documentation. They provide information on how manufacturers proceeded when preparing the clinical evaluation.
Important:
The documents must be constantly updated over the product lifetime using PMCF data.
The ongoing and regular updating of the clinical evaluation after the medical device has been placed on the market is also part of the Post Market Clinical Follow-up (PMCF).