An expert panel of the European Medicines Agency (EMA) has issued a scientific opinion on a dual chamber leadless pacemaker, a class III implantable device intended to provide bradycardia pacing via electrodes implanted in the right ventricle and right atrium. The opinion, published on 17 July 2026, was delivered under the Clinical Evaluation Consultation Procedure (CECP) following a dossier received on 19 January 2024 from Notified Body NB123.
The CECP is an additional conformity assessment step for high-risk medical devices under Article 54 and Annex IX, Section 5.1 of the Medical Device Regulation (MDR). The expert panel, composed of independent experts under MDR Article 106, evaluated the clinical evaluation assessment report (CEAR) prepared by the notified body. The panel's opinion addresses the sufficiency of clinical evidence, the benefit-risk determination, and the consistency of clinical evidence with the intended purpose and post-market clinical follow-up (PMCF) plan.
The notified body is required to give due consideration to the expert panel's views. If the experts find the clinical evidence insufficient or raise serious concerns, the notified body must advise the manufacturer on possible actions. These may include restricting the intended purpose, limiting the certificate's validity, requiring specific PMCF studies, adapting instructions for use or the summary of safety and clinical performance (SSCP), or imposing other restrictions in the conformity assessment report. Under 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 opinion covers detailed aspects required by MDR Annex IX, Section 5.1, including a summary of the expert panel's findings and recommendations. The document also notes that stakeholder information was available, and no divergent positions were recorded, indicating consensus among the panel.
This expert opinion impacts several stakeholders. For the manufacturer, the opinion may lead to additional clinical studies or restrictions on the device's use, potentially delaying market access or increasing development costs. Notified bodies must adjust their conformity assessment processes to incorporate the panel's views, which could affect their workload and liability. Healthcare providers and patients may benefit from enhanced safety and performance assurance, but could face limited device availability if restrictions are imposed. Regulators gain a more robust evidence base for decision-making, though the procedure adds complexity to the approval pathway.
The CECP procedure is a key element of the MDR's enhanced scrutiny for high-risk devices, aiming to ensure that clinical evidence is sufficient before devices reach the market. The EMA's expert panels play a central role in this process, providing independent scientific advice to notified bodies and the European Commission.