EU MDR Article 54 CECP: Expert Panel Consultation for Implantable Devices

1. Key takeaways

Under Article 54 of the MDR, when notified bodies carry out conformity assessment of Class III implantable devices and Class IIb active devices for administration and/or removal of medicinal products (ARMP), they must follow the clinical evaluation consultation procedure (CECP), under which the expert panel designated in accordance with Article 106 issues an opinion on the clinical evaluation assessment report. The designation of the expert panels rests on Implementing Decision 2019/1396, which was amended in 2025 by Implementing Decision (EU) 2025/1324.

The CECP adds a distinct institutional layer to the conformity assessment of the highest-risk device categories. Unlike documentation review, which stays within the notified body, the consultation procedure routes the clinical evaluation assessment report through an external scientific body whose opinions are published. This has three planning consequences: the timeline contains a segment the manufacturer does not control directly, the quality standard for the clinical evidence rises because the audience includes clinicians and methodologists, and the outcome of the panel review becomes part of the public record through EUDAMED. Projects in scope should budget time and expertise accordingly and should treat the panel stage as a substantive review, not a formality appended to the notified body assessment.

2. Legal basis

The consultation procedure is anchored in Article 54 of Regulation (EU) 2017/745, adopted on 2017-04-05 and applicable since 2021-05-26, with the panels constituted under Article 106. Implementing Decision 2019/1396 of 2019 designated the panels and was amended in 2025 by Implementing Decision (EU) 2025/1324. The Commission also publishes an annual overview of the procedure through staff working documents, the first of which covers the period up to 2022-06-30, giving manufacturers an empirical picture of how the consultation has operated in practice.

3. Expert insights

Insight one: the trigger for the CECP is the device type, not the willingness of the manufacturer.

Article 54(1) limits the scope to Class III implantable devices and Class IIb ARMP devices. Projects that fall within this scope must reserve time in the schedule for the expert panel stage, which is initiated by the notified body and cannot be bypassed by the manufacturer. The trigger is objective: the class and the device category decide, irrespective of the sponsor’s preference or the maturity of the evidence. Manufacturers discovering the scope late lose the most, because the panel stage affects both the calendar and the shape of the clinical evaluation assessment report; discovering it at project initiation allows the documentation to be built for that audience from the start.

Insight two: Article 54(2) provides three exemptions, and Article 54(3) requires a case-by-case notification.

The notified body must submit a notification with justification to the competent authority, the competent authority of the notified body and the Commission for every device falling within the CECP scope, stating whether the CECP applies and, if not, which of the exemptions under points (a), (b) and (c) is invoked. Consequently, even where the CECP ultimately does not apply, a notification action and its record still occur. Manufacturers should not read the exemptions as a private shortcut: each invocation is documented, justified and visible to the authorities, so the reasoning supporting an exemption must be as robust as the clinical evaluation itself, because it can be examined in later audits and enforcement proceedings.

Insight three: the panel opinion may be departed from, but the reasons must be given and published.

After receiving the opinion of the expert panel, the notified body must give it due consideration; where the opinion is not followed, the conformity assessment report must contain complete reasoning, and the Commission makes that reasoning public together with the panel opinion through EUDAMED. This mechanism turns the expert opinion from a purely advisory input into a process record with public visibility. The practical effect is that both the evidence and the disagreement about the evidence become part of the accessible record, which raises the quality bar for the clinical evaluation assessment report and rewards sponsors whose documentation anticipates the panel’s questions rather than merely responding to them.

Insight four: the composition of the expert panels changed in 2025.

Implementing Decision 2019/1396 was amended in 2025 by Implementing Decision (EU) 2025/1324, which added expert panels. Changes in panel composition directly affect which device fields can be handled and the scheduling of consultations, and the current panel setup must be verified when a project starts. A device field without a standing panel may follow a different practical pathway than the base article suggests, and a newly established panel may have limited case experience in its first period of operation. Both situations change the realistic planning assumptions, so the verification step belongs in the project initiation checklist rather than in the compliance archive.

4. Practical recommendations

1. At project initiation, determine whether the product falls within the scope of Article 54(1), and if it does, reserve the time and fees for the expert panel stage in the project plan.
2. Prepare the clinical evaluation assessment report at the granularity the expert panel will review, with conclusions and evidence chains complete and verifiable rather than summarised beyond their support.
3. Confirm with the notified body the timing of the notification under Article 54(3), so that the notification action does not become disconnected from the progress of the assessment.
4. If an exemption under Article 54(2) is claimed, prepare the written justification and supporting materials in advance, since the notification must state which exemption applies and why.
5. Check the impact of the 2025 changes to the expert panel setup on the device field concerned, and update the schedule assumptions accordingly.

5. Verification checklist

• □ Whether the product falls within the scope of Article 54(1) has been determined
• □ A clinical evaluation assessment report suitable for expert panel review has been prepared
• □ The notification arrangement under Article 54(3) has been confirmed with the notified body
• □ If an exemption is claimed, the Article 54(2) justification and supporting evidence are ready
• □ The expert panel setup after Implementing Decision (EU) 2025/1324 has been checked
• □ The project schedule includes the expert panel stage

GRZAN supports manufacturers, authorised representatives and importers across the EU MDR market with CE marking pathway selection and classification strategy, including Article 54 scope determinations, preparation of clinical evaluation assessment reports for expert panel review, and exemption justifications. For a practical estimate of consultation timelines and evidence effort for your portfolio, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 2026-10-29.