An expert panel of the European Medicines Agency (EMA) has issued a scientific opinion on a female contraceptive device, a class III implantable intended for non-surgical permanent birth control by occlusion of the fallopian tubes, under the Clinical Evaluation Consultation Procedure (CECP). The opinion, published on 10 July 2026, reflects the panel's assessment of the clinical evaluation assessment report (CEAR) submitted by Notified Body 0123. The CECP is an additional conformity assessment step for high-risk medical devices under the Medical Device Regulation (MDR) Article 54 and Annex IX, Section 5.1.
The procedure started on 11 March 2025, with the notified body seeking expert advice on the clinical evidence provided by the manufacturer. The screening experts determined that an opinion was required, assigning the case to the thematic panel for obstetrics and gynaecology, including reproductive medicine. The expert panel's opinion, detailed in the document, 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.
Under MDR rules, the notified body must give due consideration to the expert panel's views. If the panel finds the level of clinical evidence insufficient or has serious concerns about the benefit-risk balance, 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, or adapting instructions for use or the summary of safety and clinical performance (SSCP). The notified body must provide a full justification if it decides not to follow the expert panel's advice.
The opinion has significant implications for stakeholders. For the manufacturer, the device's market access may be delayed or conditioned on additional clinical data or restrictions. Notified Body 0123 faces the obligation to implement the panel's recommendations or justify any deviation, potentially increasing regulatory burden. Healthcare providers and patients may see changes in the device's availability or conditions of use, affecting treatment options for permanent contraception. The EMA expert panels, as independent advisors, reinforce their role in ensuring high-risk devices meet safety and performance standards, though their opinions are not legally binding on notified bodies.
This is the first documented CECP opinion for this device type in the EMA's published records. The procedure underscores the MDR's emphasis on rigorous clinical evaluation for high-risk implantable devices, balancing innovation with patient safety.