On 4 August 2026, the European Medicines Agency (EMA) published an expert decision and opinion on retinal stimulation systems, concluding that the clinical evidence submitted by the manufacturer is insufficient to support the intended purpose and benefit-risk profile. The opinion, issued under the Clinical Evaluation Consultation Procedure (CECP), was prepared by independent experts (MDR Article 106) and is addressed to Notified Body 0344, which is responsible for the conformity assessment of these high-risk devices. The document, dated 12 June 2026, recommends that the notified body impose restrictions on the device's intended purpose, limit the duration of certificate validity, and require specific post-market clinical follow-up (PMCF) studies before market access is granted.
The CECP is an additional conformity assessment step required under MDR Article 54 and Annex IX, Section 5.1 for certain high-risk devices. In this case, the screening experts determined that the device meets the criteria for an expert opinion, including concerns about the level of clinical evidence and the consistency of the evidence with the intended medical indication. The thematic expert panel, which reviewed the clinical evaluation assessment report (CEAR) prepared by the notified body, found that the clinical data do not adequately demonstrate safety and performance, particularly regarding long-term outcomes and the risk of adverse events such as retinal damage or device failure.
The opinion obliges Notified Body 0344 to give due consideration to the experts' views. If the notified body decides not to follow the advice, it must provide a full justification in its conformity assessment report, as required by MDR Annex IX, Section 5.1.g. The experts also recommended that the manufacturer adapt the instructions for use and the summary of safety and clinical performance (SSCP) to reflect the limitations identified. This decision follows the broader implementation of the CECP, which has been operational since 2021, and aligns with the European Commission's efforts to strengthen oversight of high-risk medical devices post-MDR.
The opinion impacts several stakeholders. For the manufacturer, the restrictions could delay market access and increase costs due to additional clinical studies and PMCF obligations. For Notified Body 0344, the opinion adds a layer of scrutiny and requires careful documentation of any deviation from expert advice. For patients, the restrictions aim to ensure that only devices with adequate evidence reach the market, reducing the risk of harm, but may also limit access to innovative treatments in the short term. For healthcare providers, the limitations on intended purpose and certificate validity may affect clinical decision-making and reimbursement pathways. The EMA's role in this procedure is to coordinate the expert panels, but the final conformity assessment decision rests with the notified body, subject to the Commission's oversight.
This is the first published expert opinion under the CECP for retinal stimulation systems, and it sets a precedent for how similar high-risk devices will be evaluated. The EMA and the Commission are expected to monitor the notified body's response and the manufacturer's compliance with the recommendations. The opinion does not specify a timeline for the manufacturer's response, but the notified body must address the expert views in its final assessment report, which will be subject to further scrutiny by national competent authorities.