use and evaluate relevant scientific literature – appropriate to the medical device – on safety, performance, design features and intended use.
The Clinical Evaluation is part of the technical documentation of medical devices and in vitro diagnostics – a part that you must carry out in order to market your medical devices safely and efficiently in Europe. This is because manufacturers must prepare a comprehensive Clinical Evaluation as part of the conformity assessment procedure in order to obtain marketing authorisation.
To increase the safety of patients and users, this is therefore subject to particularly high requirements and regulations. What you should consider and how you can compile a Clinical Evaluation without gaps? We will show you.
According to MDR (EU) 2017/745, the Clinical Evaluation serves to demonstrate compliance with the essential safety and performance requirements. It also shows that undesirable side effects have been considered and excluded during manufacture. In general, the Clinical Evaluation is therefore evidence that the medical device has an acceptable risk-benefit balance.
Since it must also be regularly supplemented and updated after the medical device has been placed on the market, patients and users benefit from a high level of safety if medical device manufacturers continuously and proactively update the assessment report throughout the entire life cycle.
Manufacturers themselves determine the scope of the document. However, this decision must be justified. According to the MDR, “the scope of the clinical evidence shall be proportionate to the characteristics of the device and its intended purpose”. (MDR, Article 61 (1)).
In addition to the systematic collection and evaluation of clinical data, the Clinical Evaluation also includes clinical follow-up after the medical device has been placed on the market (post-market surveillance).
In principle, the preparation of the Clinical Evaluation follows a systematic, defined process. Article 61 of the MDR specifies the following principles for the clinical evaluation:
See the KB not only as an obligation, but as an opportunity for your strategic planning. By integrating risk analysis and information from market research, among other things, right from the start, you create important synergies for later processes. For example, you avoid duplication of research or documentation efforts.
As already mentioned above, the following applies to the Clinical Evaluation as part of the technical documentation: After placing the product on the market, the work is not yet finally completed. As a manufacturer, you are obliged to constantly update new findings and results, because the Clinical Evaluation is part of the post-market clinical follow-up (PMCF).
Software solutions are recommended so that you can seamlessly maintain your Clinical Evaluation documentation throughout the entire life cycle of your medical device. By digitising this process, you reduce workload and keep your assessments consistent and unambiguous, as your data and analyses are updated centrally in one place. In addition, you can use existing information, e.g. the Essential Safety and Performance Requirements, for your assessment report.
From risk management to regulatory and product requirements to usability and of course the KB. With the extension module of the BAYOOSOFT Risk Manager, we enable you to generate the KB in compliance with the MDR and MEDDEV 2.7.1 rev4. Learn more.
Would you like to test the BAYOOSOFT Risk Manager free of charge? Then use our free TRIAL for 30 days.
Or visit an online product presentation and get to know the BAYOOSOFT Risk Manager directly on the system.