Detailed regulation for Joint Clinical Assessments of medical devices and IVDs was published

On October 17, 2025, the European Commission adopted an implementing regulation that sets detailed procedural rules for Joint Clinical Assessments (JCA) of medical devices and in vitro diagnostics (IVDs) under the HTA Regulation. It defines the following:

• Cooperation between the Member State Coordination Group, the Commission, notified bodies, and expert panels;
• Interaction, including the timing thereof, with and between the Coordination Group, its subgroups, and health technology developers, patients, clinical experts, and other relevant experts (‘individual experts’) during JCA and their updates;
• General procedural rules on the selection and consultation of stakeholder organisations and individual experts in JCA;
• The format and templates for dossiers with information, data, analyses, and other evidence to be provided by health technology developers for JCA;
• The format and templates for joint clinical assessment reports and summary reports. 

This is the sixth and final implementing act to support the HTA Regulation, which entered into force on 12 January 2025.

See the full details in English here and here.

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