EMA Expert Panel Consultation for Medical Devices Adds an Orphan Pathway
October 14, 2026
A revised business process description, EMA/182497/2024 (BPD/H/011), sets out the EMA expert panel consultation process for high-risk medical devices. It takes effect on 12 October 2026 and adds a new sub-process for orphan medical devices.
The European Medicines Agency plays a limited role in medical devices. It participates in the assessment of certain high-risk medical devices and in vitro diagnostics, as well as cases where a medicinal product is combined with a device. Issued by the Human Medicines Division, the description outlines the steps for these activities. Earlier Syenza coverage of expert panels for high-risk medical devices explains the wider EU framework.
The five EMA expert panel consultation procedures
| Procedure | What it covers | Output |
|---|---|---|
| Clinical Evaluation Consultation Procedure (CECP) | Screening of notified bodies’ clinical evaluation assessment reports for certain high-risk devices | An opinion where the decision criteria require one; otherwise the notified body is informed |
| Performance Evaluation Consultation Procedure | Manufacturers’ performance evaluation reports for certain high-risk in vitro diagnostic devices (IVDs) | A view from the expert panel, published after redaction |
| Advice to manufacturers | Intended clinical development strategies and clinical investigation proposals for Class III and Class IIb active devices that administer or remove medicinal products | A final advice letter from the expert panel |
| Advice to the European Commission and the Medical Device Coordination Group (MDCG) | Scientific, technical and clinical advice to support implementation of the Medical Device Regulation (MDR) | Advice published on the expert panel website |
| Orphan medical device advice | Designation of a device as an orphan, and later clinical advice for designated orphan devices, for devices of any class except IVDs | A final advice letter sent to the applicant |
Source: EMA, business process description BPD/H/011 (EMA/182497/2024), Sections 1 and 6.
How the clinical evaluation consultation works
The screening and opinion process starts when a notified body submits its clinical evaluation assessment report. The agency validates the submission and assigns a screening rapporteur and co-rapporteur. Those experts apply the decision criteria to decide whether an expert panel opinion is needed.
If no opinion is required, the notified body is told of the experts’ decision and the process ends. If one is required, an ad hoc expert group is formed, made up of a chair, a rapporteur, a co-rapporteur and reviewing members. The panel’s opinion goes to the notified body, which then issues its certification. The opinion is published after redaction where necessary.
The document also covers the case where the notified body does not fully follow the opinion. It must then send a justification, which is provided to the European Commission and subsequently published. Expert panel members are covered by the European Commission policy on managing competing interests, which the document lists among its related policies.
What changed: the orphan device sub-process
The only change since the last revision is the addition of procedural management for orphan medical device applications as a new sub-process. Advice on whether a device qualifies as an orphan, and later clinical advice for designated orphan devices, can be sought by manufacturers or by notified bodies.
The steps mirror the advice-to-manufacturers route. An applicant can first send a letter of interest. An explanatory meeting may be held to clarify process questions, and a pre-submission meeting with the chair can be arranged, with written comments provided afterwards. Validation starts the procedure. If the experts raise a list of questions, a discussion meeting with the applicant follows. The EU’s parallel work on rare-disease devices is covered in our earlier piece on orphan paediatric devices.
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