On 10 July 2026, the European Medicines Agency (EMA) published an expert decision and opinion on cardiac valves, issued in the context of the Clinical Evaluation Consultation Procedure (CECP) for high-risk medical devices. The document, dated 20 December 2025, was produced by the Expert Panels on Medical Devices (Expamed) and addresses the clinical evaluation assessment report (CEAR) of a notified body (Notified Body 0344). The opinion is a scientific assessment by independent experts under Article 106 of the Medical Device Regulation (MDR), focusing on whether the clinical evidence supports the device's intended purpose and benefit-risk determination.
The CECP is an additional conformity assessment step for specific high-risk devices, as outlined in MDR Article 54 and Annex IX, Section 5.1. The expert panel's opinion is not binding but must be given due consideration by the notified body. If the experts find insufficient clinical evidence, serious concerns about benefit-risk, or inconsistencies with the intended purpose or post-market clinical follow-up (PMCF) plan, the notified body must advise the manufacturer on possible actions. These may include restricting the intended purpose, limiting certificate validity, requiring specific PMCF studies, or adapting instructions for use or the summary of safety and clinical performance (SSCP). Under MDR Annex IX, Section 5.1.g, the notified body must provide a full justification if it does not follow the expert panel's advice.
The document includes administrative information, the screening experts' decision to provide an opinion, and the thematic panel's detailed scientific opinion. It also contains recommendations and notes any divergent positions if consensus was not reached. The opinion impacts manufacturers of cardiac valves, who may face additional requirements or restrictions based on the panel's findings. Notified bodies must adjust their conformity assessment processes accordingly. Patients and healthcare providers may benefit from enhanced scrutiny of high-risk devices, but the procedure could delay market access for new products. The European Commission oversees the process, ensuring consistency across member states.