A Medical Device manufacturer needs to justify the choice of a Clinical Evaluator for a Clinical Evaluation Report (CER). This is made through reference to their qualifications and documented experience (i.e., CV), and trough a declaration of interest for each evaluator chosen (i.e., independency).
So, who is a Clinical Evaluation Specialist according to MDR?
Someone that has knowledge of the following:
✅ Research methodology, i.e. clinical investigation design and biostatistics;
✅ Scientific background or librarianship qualification with relevant experience in databases such as Embase and Medline;
✅ Regulatory requirements; and
✅ Medical writing (e.g. post-graduate experience in a relevant science or in medicine; training and experience in medical writing, systematic review and clinical data appraisal).
In addition, with respect to the particular device under evaluation, the evaluators should have knowledge of:
✅ The device technology and its application;
✅ Diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of medical alternatives, treatment standards and technology (i.e., specialist clinical expertise in the relevant medical specialty).
Furthermore, the evaluators should have at least the following training and experience in the relevant field:
✅ A degree from higher education in the respective field and 5 years of documented professional experience; or
✅ 10 years of documented professional experience, if a degree is not a prerequisite for a given task.
This definition comes on Appendix I - Sections of MEDDEV 2.7/1 rev. 4, which according to MDCG-2020-6 are still relevant under the MDR, particularly for legacy devices.
At BioSciPons, we make sure our clinical evaluators have a ✅ in each of those bullet points.