Revised European guidance for medical devices have included comprehensive considerations relating to risk management, post-market surveillance and has introduced many pre and post-market clinical investigation requirements. The objective of the revised guidance is to facilitate the medical device manufacturers in the planning and implementation of robust and systemic clinical evaluation process and the compilation of technically valid Clinical Evaluation Reports (CERs). The guidance also includes the necessary qualification requirements for the authors and evaluators to perform clinical evaluations.
Experts in this specialized field recognize that many medical device manufacturers receive nonconformities mainly because the concerned evaluators are not adequately qualified or their qualifications were not supported with necessary documentation. Clause 6.4 of the revised MEDDEV 2.7.1 Rev 4 prescribes stricter eligibility requirements for report authors and clinical evaluators. It contains details of the essential qualifications and the supporting documentation procedures needed for medical device companies to perform clinical evaluations.
Important Qualification requirements of a Clinical Evaluator
As per the revised guidelines, each evaluator involved in the clinical evaluation process needs to be a qualified individual with sufficient knowledge of clinical study design, biostatistics, current regulatory requirements, information technology management and medical writing skills. The evaluator team and each evaluator need to have adequate technical and functional knowledge specific to the medical device under evaluation, technological know-how and operational proficiency.
The device manufacturer needs to document all the qualifications set by the company properly, and the concerned manufacturer also needs to submit a declaration of interest for each evaluator involved in the clinical investigation.
Revised European guidance requires the clinical evaluators to possess the following training and experience in their area of specialization
- A higher education degree in their respective field and five years of documented professional experience in the relevant field; or
- Ten years of documented professional experience in case if the higher education degree is not be taken into consideration for the proposed clinical evaluation of the medical device.
The manufacturer needs to take into account the following considerations to maximize the conformity to the prescribed qualification requirements of the revised European guidance related to medical devices
- The quantity and quality of the evaluators are in line with the nature, clinical performance and the associated risks of the medical device under evaluation
- Proper justification from the manufacturer regarding the choice of evaluators for clinical evaluation based on the training qualifications and documented professional experience
- Declaration of interest from the evaluators needs to have sufficient clarification relating to their individual financial interests and conflict of interest in undertaking the clinical evaluation.
In circumstances where the expertise level of the evaluators may be less or vary from the prescribed guidance, the manufacturers need to be appropriately documented and have to present proper justifications for such deviations.
Professional scientific service providers with a network of renowned medical specialists and biostatisticians meet the high requirements of the revised European guidance on authors and evaluators of clinical evaluation. Their experience and expertise in research techniques can be of great assistance to the medical device manufacturers in conducting a well-documented clinical evaluation and in the creation of comprehensive clinical evaluation report.
Contact us for more information about how we can help you comply with MEDDEV 2.7/1 rev 4 and perform clinical evaluations.
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