If manufacturers want to place your devices in European Market, they must prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV 2.7.1. rev. 4 and EU MDR Article 61 and Annex XIV part A.
Clinical evaluation report (CER) summarizes and concludes the clinical evaluation of medical devices. Clinical evaluation is responsibility of the manufacturer and is a critical step in process of CE Marking. Many manufacturers struggle and find it tedious to comply with the requirements of CER.
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In accordance with the European regulation, the clinical evaluation and the clinical evaluation report must be actively updated with data obtained from post-market surveillance. All clinical data sets shall be documented, adequately summarised, appraised, analysed and referenced) in the clinical evaluation report. The appraisal should be documented in the clinical evaluation report to the extent that it can be critically reviewed by others.
The contents of the clinical evaluation report shall be cross-referenced to the relevant documents that support them. Clinical evaluation report should include references to literature-based data and the titles and investigational codes (if relevant and available) of any clinical investigation reports, with cross-references to the location in the manufacturer’s technical documentation.
Clinical evaluation report shall also include current state of art and clinical background of the device and the evaluators should check the clinical evaluation report, provide verification that it includes an accurate statement of their analysis and opinions, and sign the clinical evaluation report.
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The MEDDEV 2.7/1 Rev 4 guidelines, released in June 2016, provide updated guidance on clinical evaluation for the medical device manufacturers and noticed bodies under directives 93/42/EEC and 90/385/EEC. The latest revision (Rev 4) effectively replaces Rev 3 published in December 2009. While the ideology of evaluating clinical evidence to demonstrate compliance with relevant Essential Requirements remains unchanged, the Rev 4 guidelines detail the requirement for clinical evaluation.
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Clinical evaluation a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant general safety and performance requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.
It has been mentioned clearly in section 6.4 of MEDDEV guideline for clinical evaluation that manufacturer should consider certain aspects in selecting the evaluators and justifying the same.
Certain aspects need to be considered while selecting a evaluator are:
Yes, clinical evaluation is an ongoing process and conducted throughout the life cycle of a medical device. Clinical evaluation is mandatory for initial CE-marking and it must be actively updated thereafter.
There guidelines/standards that must be observed when creating a clinical evaluation, such as the MEDDEV 2.7/1 Rev. 4 (2016), MDCG 2020-5 and 2020-6 or requirements & from the ISO 14155.
Clinical investigation is systematic investigation in one or more human subjects, to assess the safety or performance of a medical device and Clinical evaluation of medical devices is a systematic and planned process that contributes to the continuous generation, collection, analysis and evaluation of clinical data on a particular device.
Clinical evaluation needs to be actively updated and manufacturer need to define and justify the frequency. While deciding the frequency, manufacturer should consider whether a medical device carries a significant risks, design changes or any changes in manufacturing procedures, new information from PMS that has importance to change the current clinical evaluation.
If there is no such information is received, it has to be updated
