Second call for expression of interest in coordinated assessment of clinical investigations / performance studies
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Second call for expression of interest in coordinated assessment of clinical investigations / performance studies
Regulatory Affairs Medical Devices In Vitro Diagnostics
Monday, 17 November 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On November 10th, 2025, the EU Member States and the European Commission opened a new call for sponsors to join the pilot coordinated assessment of clinical investigations under Regulation (EU) 2017/745 (MDR) and performance studies under Regulation (EU) 2017/746 (IVDR).
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Second call for expression of interest in coordinated assessment of clinical investigations / performance studies
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The first call was launched on February 6th, 2025, and closed June 30th, 2025, but was only open to sponsors of medical device clinical investigations.
What's new in this call?
- The pilot is now open to both medical device clinical investigations and IVD performance studies.
- Interested sponsors must submit an expression of interest using the official form and email it to SANTE-CA-CIPS@ec.europa.eu by 30 April 2026.
- The eligibility criteria are clarified: the study must be multinational (involving at least two participating Member States) and subject to authorisation under MDR Art 62(1) or IVDR Art 58(1-2).
- The Commission has published an updated list of participating Member States, along with practical and organisational details for sponsors.
- The pilot continues to support the development of the future mandatory EU coordinated assessment system, allowing sponsors early experience with harmonised processes
What does this mean for you?
This renewed call is highly relevant for sponsors planning multinational clinical investigations or IVD performance studies requiring authorisation. Whether stand-alone or linked to a clinical trial of a medicinal product, participation in the pilot enables:
- reduced administrative burden,
- more transparent and predictable interactions with competent authorities,
- simplified document handling, and
- a more harmonised EU authorisation process.
If you would like to assess whether your study could benefit from inclusion in the pilot, our consultants are available to support you. Please feel free to get in touch.
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