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EMA – Publication of the Questions and answers on the information session on the pilot for expert panels’ advice for orphan medical devices held the 23 September 2024

EMA is initiating a new pilot programme for the expert panels to support manufacturers manufacturing and notified bodies certifying orphan medical devices with the challenges linked to generating clinical evidence for these devices in the premarket phase (see Medical devices). 

The expert panels can offer advice on the orphan device’s status, the intended clinical development strategies, proposed clinical investigations, or on the data required for the clinical evaluation during an ongoing conformity assessment. This programme is being launched as a pilot to help implement the processes outlined in the MDCG 2024-10 document on clinical evaluation of orphan medical devices.

On 23 September 2024 was held an information session/webinar covering cover the following topics:

  • Introduction of the new definition and criteria for the orphan status for medical devices in the EU;
  • Strategies for manufacturers to overcome the challenges in generating clinical evidence for orphan devices considering the limitations in pre-market clinical data and how the post-market phase can be utilised to mitigate such limitations;
  • Overview of the new pilot programme and how to apply for scientific support from the expert panels;
  • Demo of the submission portal.

Following the webinar, the EMA published a document providing answers to the most frequently asked questions received before, during and after the webinar.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (11 décembre 2024). EMA – Publication of the Questions and answers on the information session on the pilot for expert panels’ advice for orphan medical devices held the 23 September 2024. ELSIBI. Consulté le 18 mars 2025 à l’adresse https://doi.org/10.58079/12wca


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