Expert panels on medical devices and in vitro diagnostic devices (Expamed)
This scientific opinion represents independent specialists’ opinions (MDR Article 106) on the notified body’s Clinical Evaluation Assessment Report (CEAR). Clinical Evaluation Consultation Process (CECP) is an extra aspect of conformity assessment by recognized organizations for high-risk devices (MDR Article 54 and Annex IX, Section 5.1).
The notified body must consider the scientific opinion of the expert panel, especially if experts find the level of clinical evidence insufficient or have serious concerns about the benefit-risk determination, the consistency of the clinical evidence with the intended purpose, including medical indication(s), or with the post-market clinical follow-up (PMCF) plan.
After considering expert opinions, the notified body must 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.
According to MDR Annex IX, 5.1.g, the notifying body must explain in its conformity assessment report why it did not adopt the expert panel’s suggestion.
This consultation relates to a Class III implanted device for abdominal soft tissue strengthening in ventral and hiatal hernia repair operations in the medical fields of General and plastic surgery and dentistry.
This expert panel concurs with the NB’s evaluation of the appropriateness and sufficiency of the manufacturer’s clinical data, as well as the assessment of the benefit-risk ratio.
Recent publication of a new multicenter research adds 84 patients with a 24-month follow-up to the previously analyzed data (Van Rooijen, 20224). Overall, there is no indication that this technology has a higher recurrence or complication rate compared to established routine techniques. Despite this, the number of patients included in the various trials and registries is quite small, and the duration of follow-up is rather brief.
The PMCF Plan calls for the collecting of additional clinical data, and this was deemed acceptable to create more clinical data and identify long-term adverse effects, such as those induced by device-tissue interaction. In addition, the device will be tracked in two quality registries (HerniaMed and ACHQC) to expand the existing clinical data and monitor the device for the duration of its estimated lifespan.