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

On 28 May 2025, the European Commission opened a consultation on the draft Implementing Regulation for joint clinical assessments under the Health Technology Assessment Regulation (2021/2282), until 25 June 2025. 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.