Scientific advice for high-risk medical devices

Guidance for manufacturers on requesting clinical advice from the European Medicines Agency (EMA) through expert panels for high-risk medical devices.

EMA is offering clinical advice to manufacturers of high-risk medical devices through expert panels.

The expert panels advise on intended clinical development strategies and clinical investigation proposals. This is line with the Medical Devices Regulation (Article 61(2) of Regulation (EU) 2017/745).

The advice applies for the following devices: 

• Class III medical devices
• Class IIb active medical devices intended to administer or remove medicinal products from the body

For more information on high-risk medical devices, see:

• High-risk medical devices

Guidance

Guidance for manufacturers is available below, including step-by-step instructions.

EMA ensures the expert panel secretariat. It coordinates the advice procedure and acts as the main contact point for applicants.

The regular advice procedure has been in place since February 2025, following the successful completion of a two-year pilot.

Guide to manufacturers on the procedure for requesting advice from expert panels on clinical investigations and / or clinical development strategies for high-risk medical devices

Reference Number: EMA/23357/2025

For more information, see: 

• Expert panels

How to apply: step by step

1. Create an EMA account (if you don't have one)

You can request this type of advice if you are an EU-based manufacturer or their authorised representative.

To do so, create an EMA account via the link below: 

• EMA Account Management

2. Open letter of interest

To request advice, open the 'letter of interest' form available on the dedicated portal linked below (if you already have an EMA account): 

• Letter of interest - Expert panels

Note that the link above also serves to request advice on orphan medical devices. 

Find more information on the 'Expert panels support for orphan medical devices: pilot programme' section on this page. 

3. Select application type 

To correctly complete and submit the letter of interest form, select the “Scientific Advice according to Art. 61(2) of the MDR” option from the corresponding drop-down list.

4. Check final briefing document timeline

While you can submit a letter of interest at any time, you can only submit the required final briefing document according to the 2025 timetable available below:

Advice to medical device manufacturers - 2025 Timetable

Advice to medical device manufacturers - 2026 Timetable

Briefing document template

A briefing document template (in PDF format) is available for information. 

Applicants will receive a Word version of this template that they need to fill in during the application.

Request for advice on the clinical development strategy and / or clinical investigations according to Article 61(2) of Regulation (EU) 2017/745 on <device name> from the medical device expert panels

Contact

For any questions not addressed in the guidance on this webpage, you can get in touch at [e-mail].

Pilot report

EMA successfully established this procedure via a pilot launched in February 2023. 

An interim report on the pilot in also available below. 

Pilot on advice from expert panels to manufacturers of high-risk medical devices: Interim report on the experience with the pilot from February 2023 to December 2024

For more information, see: 

• EMA pilots scientific advice for certain high-risk medical devices (27/02/2023)

Page update history

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.

See update history

2 March 2026

Page first published; Content has been moved from another webpage