European Union: European Commission closes consultation on joint clinical assessment procedures for medical devices

On 25 June 2025, the European Commission closes the consultation on the draft Implementing Regulation for joint clinical assessments under the Health Technology Assessment Regulation (2021/2282). The consultation invites feedback on procedural rules governing cooperation between national authorities and expert panels in evaluating medical devices. The regulation aims to streamline assessments, reduce duplication across member states, and promote shared use of resources while respecting national competencies. The proposed regulation also sets out requirements for timely EU-level evaluations with expert input, including specific reporting obligations for medical devices that use artificial intelligence or machine learning.