Adoption of Decision 2025/1324 on expert panels in the field of medical devices
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Adoption of Decision 2025/1324 on expert panels in the field of medical devices
Regulatory Affairs Medical Devices In Vitro Diagnostics
Tuesday, 30 September 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On 7 July 2025, Commission Implementing Decision (EU) 2025/1324 was published in the Official Journal of the European Union, which amends Implementing Decision (EU) 2019/1396 to streamline certain administrative aspects related to expert panels and introducing a new expert panel in the field of medical devices.
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Adoption of Decision 2025/1324 on expert panels in the field of medical devices | QbD Group
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The new panel can provide scientific and clinical advice for devices intended for small patient populations, such as children and patients with rare diseases. It also reflects the transfer of the secretariat function for expert panels to the European Medicines Agency from March 2022, and incorporates adjustments based on practical experience, including changes to the timing of publication of scientific opinions and the remuneration of experts involved in the development and review of guidance, common specifications, and standards.
What does this mean for you?
Manufacturers developing devices for niche populationsshould be aware that additional expert panels are now available for consultation, which may facilitate scientific advice and guidance. Administrative and procedural changes may also impact submissions or interactions with expert panels
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