Insights from expert panels on the EU clinical evaluation consultation procedure.

Hilde Bastaerts; Francesca Romana Del Vecchio; Miguel Antunes; Iordanis Sidiropoulos; C&#xe9;cile Henrot; Agnieszka Ciarka; Volker Dietz; Per Kj&#xe6;rsgaard-Andersen; Ernst Klar; Rob Nelissen; Vasileios Sakalis; Iana Simova; Raul Sousa; Sven Zenker; Silvy da Rocha Dias

doi:10.1080/17434440.2026.2705491

PubMed · 42517658

Insights from expert panels on the EU clinical evaluation consultation procedure.

Hilde Bastaerts·Francesca Romana Del Vecchio·Miguel Antunes·Iordanis Sidiropoulos·Cécile Henrot·Agnieszka Ciarka·Volker Dietz·Per Kjærsgaard-Andersen·Ernst Klar·Rob Nelissen·Vasileios Sakalis·Iana Simova·Raul Sousa·Sven Zenker·Silvy da Rocha Dias

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Abstract

BACKGROUND: The Clinical Evaluation Consultation Procedure (CECP) under the EU Medical Device Regulation aims to strengthen and harmonize the assessment of high-risk medical devices. This review summarizes early insights from expert panels to support improved clinical evaluation practices. RESEARCH DESIGN AND METHODS: This review analyses 34 expert panel opinions derived from 281 CECP submissions between April 2021 and December 2025. Statements from opinions were systematically extracted, de-duplicated, and grouped into thematic categories, with independent review and validation. The analysis focuses on common challenges found during the consultation procedure of the expert panels on the content of the clinical assessment in relation to clinical evidence, benefit-risk assessment, intended purpose alignment, and post-market clinical follow-up planning. RESULTS: Expert panel findings highlight recurrent issues in the sufficiency, consistency, and transparency of clinical evidence, underscoring the need for improved standardization and clearer guidance. CONCLUSIONS: Strengthening documentation quality and alignment across stakeholders will enhance the robustness, efficiency, and predictability of conformity assessments for high-risk medical devices.

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Humans European Union Equipment and Supplies Risk Assessment Referral and Consultation Clinical evaluation consultation procedure European medicines agency expert panels high-risk medical devices medical device regulation medical devices in Europe Journal Article Review

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Hilde Bastaerts, Francesca Romana Del Vecchio, Miguel Antunes, Iordanis Sidiropoulos, Cécile Henrot, Agnieszka Ciarka, Volker Dietz, Per Kjærsgaard-Andersen, Ernst Klar, Rob Nelissen, Vasileios Sakalis, Iana Simova, Raul Sousa, Sven Zenker, Silvy da Rocha Dias. 2026-07-28. Insights from expert panels on the EU clinical evaluation consultation procedure.. https://doi.org/10.1080/17434440.2026.2705491

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