This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The advice is provided in the context of the clinical evaluation consultation procedure (CECP), which is an additional element of conformity assessment by notified bodies for specific high-risk devices (MDR Article 54 and Annex IX, Section 5.1).
The notified body is obliged to give due consideration to views expressed in the scientific opinion of the expert panel and in particular in case experts find the level of clinical evidence not sufficient or have serious concerns about the benefit-risk determination, the consistency of the clinical evidence with the intended purpose including the medical indication(s) or with the post-market clinical follow-up (PMCF) plan.
Having considered the expert views, the notified body must, if necessary, advise the manufacturer on possible actions, such as specific restrictions of the intended purpose, limitations on the duration of the certificate validity, specific post-market follow-up (PMCF) studies, adaption of instructions for use or the summary of safety and clinical performance (SSCP) or may impose other restrictions in its conformity assessment report.
In accordance with MDR Annex IX, 5.1.g., the notify body shall provide a full justification where it has not followed the advice of the expert panel in its conformity assessment report
Opinion in the context of the Clinical Evaluation Consultation Procedure (CECP)
Expert panels on medical devices and in vitro diagnostic devices (Expamed)