EMA Med.Dev Guidance: Guide to Requesting Advice from Expert Panels for Orphan Medical Devices

The guidance Guide to manufacturers and notified bodies on the procedure for requesting advice from expert panels for orphan medical devices was published on 31 March 2026, outlining the procedural framework and expectations for applicants seeking scientific and regulatory advice.

Orphan medical devices are those intended for the diagnosis, prevention, or treatment of rare conditions, where limited patient populations create challenges in generating extensive clinical evidence, making expert guidance critical.

Expert panel advice provides scientific and regulatory support to applicants, particularly in defining appropriate clinical development strategies and ensuring that clinical evidence requirements are adequately met.

Background Information

Basis: The provision of advice from expert panels for orphan medical devices is based on MDCG guidance 2024-10. While formal legislative provisions are not yet fully incorporated, they are expected in future revisions of the Medical Device Regulation (MDR).

Pilot Phase: A pilot programme for orphan medical devices was launched on 2 August 2024. Following its successful implementation, the EMA has now transitioned to a fully operational programme, extending its applicability across all device classes.

Scope

Applications can be submitted by either:

• Manufacturers

• Notified bodies

depending on the stage of device development.

For applicants outside the EU, EEA, or Turkey, the involvement of an EU authorised representative is mandatory.

The programme now covers all classes of medical devices, ensuring broad applicability.

Clinical advice provided under this programme includes:

• Guidance on clinical development strategy for early-stage devices

• Advice on clinical data requirements for clinical evaluation in later stages

However, such advice is only applicable to devices that have already been designated as orphan devices. For non-orphan devices meeting specific criteria (e.g., Class III or certain Class IIb devices), alternative procedures under Article 61(2) of MDR may be used.

Fees

Currently, no fees are charged for participation in this programme, encouraging wider engagement from applicants.

Procedure and Instructions for Application

The procedure applies to both orphan status requests and clinical advice requests, following a structured multi-step approach.

Step 1: Letter of Interest

Applicants must submit a Letter of Interest via the EMA ServiceNow platform, selecting the relevant option under MDCG guidance 2024-10.

An EMA account is required to access the system, and upon submission, applicants can communicate with EMA and upload documents through the created ticket.

EMA confirms receipt and may schedule an explanatory meeting.

Step 2: Exploratory Meeting

The applicant presents an overview of the device and its development stage.

EMA provides clarification on the procedure and addresses any procedural queries.

Step 3: Draft Briefing Document Submission

Applicants must prepare and submit a draft briefing document using the EMA template available on the official webpage.

The document should include structured questions and relevant details about the device.

EMA reviews the submission and schedules a pre-submission meeting or provides written feedback.

Step 4: Pre-submission Meeting

During this stage, applicants present their device and proposed questions.

The expert panel chair and EMA provide feedback on:

• Clarity of questions

• Completeness of the briefing document

• Potential improvements

Written feedback is also provided after the meeting.

Step 5: Final Briefing Document Submission and Start of Procedure (Day 1)

Applicants submit the final version of the briefing document, incorporating feedback.

EMA validates the application and initiates the procedure, informing applicants of timelines and scheduling potential discussion meetings.

Step 6: List of Questions from Expert Panel

The expert panel may provide a list of questions seeking:

• Clarifications

• Addressing disagreements

If no questions arise, this step is omitted.

Step 7: Discussion Meeting and Written Responses

Applicants prepare responses to the expert panel’s questions and present them during the meeting.

Within 2 working days, written responses must be submitted, reflecting the discussion outcomes.

Step 8: Delivery of Advice (Day 60)

Final advice from the expert panel is provided within the defined timeline and shared via the ServiceNow platform.

Steps After the Procedure

Publication of Advice

While individual advice provided to applicants remains confidential, aggregated procedural information may be published or presented by the EMA for transparency and stakeholder engagement.

Considerations for Manufacturers

Manufacturers must give due consideration to the expert panel’s advice.

This may require:

• Additional studies or data generation

• Updates to the Clinical Evaluation Report (CER)

• Sharing the advice with notified bodies as part of regulatory documentation

Considerations for Notified Bodies

Notified bodies are expected to incorporate expert panel advice into their clinical evaluation assessments.

If there is any divergence from the expert panel’s recommendations, it must be:

• Clearly justified

• Documented in the assessment report

References

For complete official guidance, refer to:

Guide to manufacturers and notified bodies on the procedure for requesting advice from expert panels for orphan medical devices – EMA