The European Commission adopted on 17 October 2025 the implementing regulation establishing the rules for joint clinical assessments of medical devices and in vitro diagnostics. This is the final implementing regulation adopted under the Health Technology Assessment (HTA) Regulation.
It sets out detailed procedural rules for the joint clinical assessments, including the cooperation of the Member State Coordination Group on HTA and the Commission with the notified bodies and with the expert panels. It also sets out how the the Coordination Group and its subgroups interact with health technology developers, patients, clinical experts and other relevant experts. Furthermore, it establishes the general procedural rules for selecting and consulting stakeholder organisations and individual experts.
The implementing regulation also specifies the format and templates for the dossiers containing information, data, analyses and other evidence to be provided by health technology developers, as well as for joint clinical assessment reports and summary reports.