Another medical device preliminarily selected for EU Joint Clinical Assessment

On 28 October 2026, the European Commission published a draft implementing act concerning the selection of medical devices for Joint Clinical Assessment (JCA) at the EU level under Regulation (EU) 2021/2282.

The Commission considered two medical devices recommended for assessment by the Member State Coordination Group on Health Technology Assessment (HTACG) in July 2026:

• PRIMA Products: A technology intended to restore limited visual perception in severely sight-impaired patients who have lost central vision due to photoreceptor degeneration caused by atrophic dry age-related macular degeneration (AMD). The intended population includes patients with a functional optic nerve and retinal ganglion cell layer.
• Disposable Cervical Photodynamic Therapy Lamp (CEVIRA device): A device intended for treating adult women (≥18 years) with histologically confirmed cervical high-grade squamous intraepithelial lesions.

The European Commission concluded that PRIMA Products meet the following selection criteria under Article 7(4) of Regulation (EU) 2021/2282: unmet medical needs; first-in-class technology; potential impact on patients, public health, or healthcare systems; and Union-wide added value.

Based on these criteria, the Commission proposed selecting PRIMA Products for JCA at the EU level.

For the CEVIRA device, the health technology developer confirmed that the device does not have an independent therapeutic indication. Its use is restricted to the authorized therapeutic indication of the associated medicinal product, which is currently under evaluation by the European Medicines Agency (EMA). Consequently, the Commission concluded that a JCA would primarily concern the associated medicinal product rather than the medical device itself and proposed not selecting CEVIRA for a medical device JCA.

The draft implementing act is scheduled for discussion at the HTA Committee meeting on 13 November 2026. The formal adoption of the Commission Implementing Decision will follow the applicable committee procedure.

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