MDR Article 54 procedure in which an independent expert panel reviews the notified body's clinical evaluation assessment for certain Class III and implantable Class IIb devices.

Definition

The Clinical Evaluation Consultation Procedure is set out in MDR Article 54 and detailed in Annex IX Section 5.1. It requires the notified body to notify the European Commission of its clinical evaluation assessment report for implantable Class III devices and certain implantable and Class III active devices that administer or remove a medicinal product, so that an independent expert panel can scrutinise the manufacturer's clinical evaluation. The expert panel may issue a scientific opinion within 60 days (extendable), and while the notified body is not bound by it, Annex IX requires the notified body to duly consider the opinion and document its final position in the conformity assessment.

Why it matters

CECP does not apply to every Class III or implantable device: Article 54(2) and Annex IX Section 5.1 carve out exceptions for renewals of existing certificates without significant changes, devices already CE-marked and modified only in specific limited ways, and certain well-established device types (as clarified in MDCG guidance). CECP was designed as a check on notified body inconsistency for the highest-risk devices, echoing lessons from cases such as the PIP breast implant scandal that preceded the MDR.

Common pitfalls

•Assuming all Class III implantables automatically require CECP; several exemptions in Article 54(2) and MDCG 2019-3 can remove the obligation.
•Underestimating the added 60-plus day timeline for expert panel review when planning a certification schedule for a novel implantable device.
•Treating a favorable expert panel opinion as a guarantee of certification; the notified body retains final decision authority and may still require additional clinical evidence.

Sources

Regulation (EU) 2017/745, Article 54 and Annex IX Section 5.1 · EUR-Lex
MDCG 2019-3 Rev.1, Interpretation of Article 54(2)(b) · MDCG
RAPS Regulatory Focus · RAPS

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