Clinical Evaluation Consultation Procedure
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.What this means in practice
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.- •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.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/745 governing medical devices in the European Union.
EU-designated organization that assesses conformity of medical devices under MDR and IVDR.
Additional expert-panel review of a notified body's assessment for certain novel or high-risk Class D devices before certification.
EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER).
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1Regulation (EU) 2017/745, Article 54 and Annex IX Section 5.1Tier 1 VerifiedEUR-Lexeur-lex.europa.eu
- 2MDCG 2019-3 Rev.1, Interpretation of Article 54(2)(b)Tier 2 UncheckedMDCGhealth.ec.europa.eu
- 3RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
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