EMA has established a voluntary process enabling manufacturers of orphan medical devices and notified bodies to request support from relevant expert panels.
The support applies to all classes of devices, in line the Medical Device Coordination Group's guidance on the clinical evaluation of orphan medical devices.
It is free of charge.
This followed an expert panel support pilot that ran between 2024 and 2026.
EMA ensures the secretariat of the expert panels. It coordinates the support process and acts as the main contact point for applicants.
For more information, see:
For applications from manufacturers, the expert panels will advise:
For applications from notified bodies, the expert panels will advise:
Notified bodies will submit their advice request in cooperation with the orphan device manufacturer.
The request for advice depends on the stage of development of the device.
The first step is getting an opinion on the orphan device status. This enables asking for clinical advice for devices that are granted an orphan device designation. Clinical advice may include an opinion on:
The Paediatrics and rare diseases expert panel is the main panel involved in orphan device applications. Experts can be recruited from the other thematic panels as necessary.
For more information, see:
EMA guidance for manufacturers / applicants is available below, including step-by-step instructions.
Guidance is also available to help determine when a medical device or an accessory for a medical device should be regarded as ‘orphan’. This guidance provides a benchmark to manufacturers and notified bodies on the clinical evaluation of orphan devices which require clinical data evidence to demonstrate conformity with the Medical Device Regulation (Regulation (EU) 2017/745). The from Medical Devices Coordination Group (MDCG) published the guidance in June 2024.
For more information, see:
To submit your application, follow the steps described in the expandable panels below:
You can request this type of advice if you are an EU-based manufacturer or their authorised representative, or a notified body designated under the Medical Device Regulation.
To do so, create an EMA account via the link below:
To request advice, open the 'letter of interest' form available in the dedicated portal linked below (if you already have an EMA account):
Note that the link above also serves to request other types of support from the expert panels.
To correctly complete and submit the letter of interest form, select the “Advice in scope of the MDCG guidance 2024-10” option from the corresponding drop-down list.
While you can submit a letter of interest at any time, you can only submit the required final briefing document according to the 2026 timetable available below:
Briefing document templates in PDF format are available for orphan designation and clinical advice.
Applicants receive a Word version of the template that they need to fill in during their application.
For more information, see:
For any questions not addressed in the available guidance, you can get in touch at eu-operations-expamed@ema.europa.eu.
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in March 2026.
1 April 2026
Page updated to reflect the availability of an established expert panel support process for manufacturers of orphan medical devices and notified bodies. This includes new guidance for applicants, detailed information on how to apply and new briefing document templates.
2 March 2026
Page first published; Content has been moved from another webpage as part of a broader content reorganisation