Expert panel support for orphan medical devices

Manufacturers of high-risk medical devices and notified bodies can apply for the European Medicines Agency's (EMA) pilot programme to support orphan medical devices.

EMA's pilot programme to support orphan medical devices provides free advice on a possible orphan device status and on the clinical evaluation of orphan medical devices.

The aim is to help both new orphan medical devices and legacy medical devices, which are transitioning under rules of the Medical Device Regulation (EU) 2017/745 (MDR). Concretely, it aims to help bring new orphan medical devices onto the EU market while also keeping legacy medical devices on the EU market.

The pilot programme was designed to run until the end of 2025, but applications are still accepted.

The pilot aims to establish a long-term process for requesting orphan device support from the expert panels.

Click on the expandable sections below for information on the application process. 

How it works

For selected proposals from manufacturers, the expert panels will advise:

• regarding a possible orphan status of a device;
• and on the clinical development strategy and / or proposals for clinical investigation for the respective device.

For selected proposals from notified bodies, the expert panels will advise:

• either on a possible orphan status of a device;
• or on the data required for the clinical evaluation during an ongoing conformity assessment.

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. It may include an opinion on:

• orphan device status;
• data sets required for the clinical evaluation as part of the conformity assessment;
• review of the justification regarding the limited clinical data;​
• acceptability of clinical uncertainty and limitations in the data sets;
• acceptability of the proposed post-market clinical follow-up activities.

The pilot programme will prioritise certain groups of orphan medical devices:

• Devices for treating medical conditions that are life threatening or cause permanent impairment of a body function
• Devices intended for children
• Novel devices with a potential major clinical benefit

How to apply

Submit your application at any time via the dedicated portal linked below:

• Letter of interest for the pilot phase of scientific advice provided by the expert panels on certain high-risk medical devices

Please note that to access the application you need to log in with your EMA account. If you do not have one, please visit the EMA Account Management website and follow the steps under 'Create an EMA account'.

In your application, you should clearly elaborate on:

• specific issues to be addressed concerning the orphan device status and / or the clinical data set needed for the pre-market clinical evaluation;
• post-market clinical follow-up activities to address the limitations in the pre-market clinical data.

Guidance

Guidance is available to help determine when a medical device or an accessory for a medical device should be regarded as ‘orphan’.

The guidance also 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 MDR.

The Medical Devices Coordination Group (MDCG) published the guidance in June 2024:

• Medical Device Coordination Group: Clinical evaluation of orphan medical devices

Application templates

Application templates in PDF format are provided for information purposes. Word documents to be filled in will be sent to the applicant during the procedure:

Template - Request for advice on the orphan device status pursuant to Article 61(2) of Regulation (EU) 2017/745 and MDCG 2024-10

Summary:

For information only. Word documents to be filled in will be sent to the applicant during the procedure.

Template - Request for advice on the clinical development strategy or clinical data required for the clinical evaluation pursuant to Article 61(2) or Article 106(11) of Regulation (EU) 2017/745 and MDCG 2024-10 on <device name> from the Expert Panels

Summary:

For information only. Word documents to be filled in will be sent to the applicant during the procedure.

Page update history

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The tracking of updates begins in March 2026.

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2 March 2026

Page first published; Content has been moved from another webpage as part of a broader content reorganisation