
Manufacturer's clinical evaluation report
The manufacturer's clinical evaluation (report) is a key document in proving clinical effectiveness and safety in clinical trials in the form of the clinical evaluation. The report is generally based on the requirements of MEDDEV-2.07-1-rev 4 Clinical Evaluation: Guidance for Manufacturers and Notified Bodies.
Clinical evaluation is conducted by collecting and analyzing clinical literature regarding the intended use of the medical device and includes the following key points:
Identification of the intended use and planning of the clinical evaluation,
Identification of relevant data (standards and clinical data)
Evaluation of each individual data set for scientific validity, relevance and weighting, including:
Searching and analyzing literature publications supporting the safety and effectiveness of the medical device.
Providing data for the period of commercialisation of the medical device to confirm safety and effectiveness
Demonstrating equivalence between the intended use and claimed properties and performance and safety of the medical device and a device that has already been on the market.
Analyzing the data through which conclusions are drawn about the key claims related to clinical effectiveness and safety, including the total clinical risk/benefit, analyses of information in the user manual (instructions for use), residual risks and PMS (post-market surveillance).