Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
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An opportunity to apply for Joint Scientific Consultations is open within the EU HTAR framework
From April 1 to April 29, 2026, the submission period is open for Joint Scientific Consultations (JSCs) requests under the EU Health Technology Assessment Regulation (HTAR) framework. JSCs allow developers to consult on study planning for their products, focusing on the data and evidence needed for an eventual Joint Clinical Assessment. This process is intended to support more efficient evidence generation and improve the overall quality of submissions.
Developers of medical devices and medicines can now submit requests (using dedicated templates) for the following planned JSC time slots:
- Briefing document by July 6, 2026;
- Briefing document by August 31, 2026;
- Briefing document by September 28, 2026.
The briefing document is a more detailed dossier submitted after a JSC request has been approved. Briefing document templates for medical devices and in vitro diagnostics can be accessed here.
See the full details in English here.
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