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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 populations should 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
