COMMISSION IMPLEMENTING REGULATION (EU) laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices

The "Commission Implementing Regulation (EU) 2025/117" has been "PUBLISHED" by the "European Commission" on "24/01/2025". This regulation establishes detailed rules for implementing Regulation (EU) 2021/2282 concerning joint scientific consultations on medical devices and in vitro diagnostic medical devices. It aims to enhance cooperation between Member States by providing a framework for health technology developers to receive guidance from the Member State Coordination Group on the clinical evidence required for joint clinical assessments. Key provisions include the establishment of annual request periods, the use of a secure HTA IT platform for submissions, and the possibility for consultations to occur in parallel with expert panel consultations under Regulation (EU) 2017/745.