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Clinical Evaluation Report
- 2. CONTENT Clinical Evaluation Report M EDDEV 2.7/1Rev 4 Guideline FAQ
- 3. CLINICAL EVALUATION REPORT 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.
- 4. 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 M DR Article 61and Annex XIV part A. Maven Profcon Services LLP. has a team of experienced professionals who are well versed with the CE regulations and literature reviews to compile your CER.
- 5. 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. clinical evaluation report. The appraisal should All clinical data sets shall be documented, adequately sum m arised, appraised, analysed and referenced) in the be docum ented in the clinical evaluation report to the extent that it can be critically reviewed by others.
- 6. 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.
- 7. MEDDEV 2.7/ 1Rev 4 Guideline 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.
- 8. FAQ 1. What is clinical evaluation? 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.
- 9. 2. Who can perform the clinical evaluation? It has been m entioned clearly in section 6.4 of M EDDEV guideline for clinical evaluation that consider certain aspects in selecting m anufacturer should the evaluators and justifying the same. Certain aspects need to be considered while selecting a evaluator are: Evaluators should possess a knowledge and experience in research methodology and systemic search strategy using certain databases.
- 10. Prior knowledge in regulatory requirements and in medical writing where experts in systemic reviewing of the literature and clinical data appraisal Knowledge of device technology and its application A degree from respective field and 5 years documented professional experience or 10 years of documented professional experience if degree is not a pre-requisite.
- 11. 3. What is difference between clinical evaluation and clinical investigation? 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.