The clinical evaluation consultation procedure (CECP) under MDR Article 54 is an additional layer the notified body must trigger for certain Class III implantable devices and certain Class IIb active devices intended to administer or remove a medicinal product before it can issue a CE certificate. Under Article 54(1) and Annex IX Section 5.1 of Regulation (EU) 2017/745, the notified body submits its clinical evaluation assessment report, together with the manufacturer's clinical evaluation documentation, to an EU-level expert panel designated under Article 106. The panel, within a defined timeframe, may deliver a scientific opinion that the notified body must give due consideration to. The CECP is not the Article 55 scrutiny procedure and it is not an approval gate per se, but in practice a CER that is not written to survive expert panel review is a CER that will come back with questions that delay certification by months.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • The CECP is defined in MDR Article 54 and procedurally detailed in Annex IX Section 5.1. It is triggered by the notified body, not by the manufacturer, and the expert panel is an EU-level body designated under Article 106.
  • Scope is narrow and specific: Class III implantable devices, and Class IIb active devices intended to administer or remove a medicinal product, subject to the exclusions in Article 54(2). Most Class III devices are out of scope.
  • The notified body submits its clinical evaluation assessment report to the panel together with the manufacturer's clinical evaluation and the CER. The panel decides whether to provide a scientific opinion.
  • The panel's scientific opinion is not binding in the sense of a formal veto, but the notified body must give due consideration to it under Article 54(1) and justify any deviation in its certification decision.
  • The CECP is distinct from the Article 55 scrutiny procedure. Article 55 concerns information flow and transparency on certain certification decisions. Article 54 concerns pre-certification scientific consultation by an expert panel on clinical evidence.
  • For a startup, the practical question is not "can we avoid CECP" (you cannot, if your device is in scope) but "is our CER written so that an EU expert panel reading it for the first time can reach a clear conclusion without sending back a list of clarifications."

Why the CECP matters for your startup

Felix has watched two first-time Class III implantable founders realise, six weeks before their planned certification milestone, that their clinical evaluation report had never been stress-tested against the reality that a group of independent experts outside their notified body was going to read it. The CER had been written for the notified body reviewer they had already talked to. It had not been written for an EU-level expert panel that would see the device for the first time in the CECP submission package.

In both cases the expert panel came back with questions. Not rejections — questions. But questions in the CECP turn into clarifications to the notified body, which turn into clarifications to the manufacturer, which turn into CER amendments, which turn into re-submission cycles, which turn into months. For a startup burning runway, a three-month CECP-driven delay is a strategic event.

The point of this post is to name what the CECP actually is, where it sits in the MDR text, what triggers it, what the expert panel does and does not do, and how to write a CER that treats the expert panel as a reader from the first draft — so that the CECP is a procedural step rather than a re-opening of the clinical evidence strategy.

The MDR text — what Article 54 and Annex IX Section 5.1 actually say

The anchor is Article 54 of Regulation (EU) 2017/745, titled "Clinical evaluation consultation procedure for certain class III and class IIb devices."

"In the case of class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of Annex VIII (Rule 12), notified bodies shall, following a positive assessment of the clinical evaluation by the manufacturer, draw up a clinical evaluation assessment report..." — Regulation (EU) 2017/745, Article 54, paragraph 1.

Article 54(1) goes on to require the notified body to submit the clinical evaluation assessment report, along with the documentation referred to in Sections 6.1(c) and (d) of Annex II, to the Commission, which then forwards it to the expert panel designated under Article 106 to decide whether to provide a scientific opinion.

Article 54(2) sets out exclusions from the CECP, including renewals of certificates for devices already on the market, devices covered by common specifications, and certain certificate modifications. These exclusions are specific and must be read from the article text directly — they are not a general escape hatch.

Annex IX Section 5.1 provides the procedural detail: the notified body's clinical evaluation assessment report is drawn up on the basis of the clinical evaluation carried out by the manufacturer and the notified body's own assessment. The content is specified — the expert panel will see the manufacturer's clinical evaluation, the notified body's assessment of it, and the documentation package described in Annex II Sections 6.1(c) and (d).

Article 106 establishes the expert panels. The Commission, in consultation with the Medical Device Coordination Group, designates panels composed of experts with demonstrated scientific and clinical competence in the relevant medical field. The panels provide scientific, technical, and clinical assistance to the Commission, MDCG, manufacturers, and notified bodies.

The scientific opinion of the expert panel is not a binding approval or rejection. But Article 54(1) requires the notified body to give due consideration to the views expressed in the scientific opinion, and to document its reasoning where it deviates. In the real world of notified body practice, a panel opinion that raises concerns is extremely hard to overrule without addressing the concerns in the clinical evidence package.

CECP is not the Article 55 scrutiny procedure — the distinction matters

This is one of the most common sources of confusion among first-time founders, and it matters because the two procedures live in adjacent articles of the MDR and both involve EU-level visibility for certain high-risk devices.

Article 54 — CECP — is a pre-certification scientific consultation on clinical evidence. The notified body submits the clinical evaluation assessment report to an expert panel designated under Article 106. The panel may provide a scientific opinion. The notified body gives due consideration to that opinion before issuing a certificate.

Article 55 is a separate provision on the information flow and transparency for certain certification decisions for Class III implantable devices and certain Class IIb active devices. It addresses how information about certification decisions reaches the Commission, the MDCG, and the public, and the mechanisms by which concerns can be raised about individual certification decisions.

In short: Article 54 is about scientific consultation on the clinical evidence before certification. Article 55 is about information flow and transparency around the certification decision itself. A device can be in scope for both, and the procedural sequencing matters for timeline planning.

What triggers the CECP and what the scope actually covers

The scope under Article 54(1) is precise and narrow, not a catch-all for "all high-risk devices." It covers:

  • Class III implantable devices, as classified under Annex VIII of the MDR.
  • Class IIb active devices intended to administer and/or remove a medicinal product, classified under Annex VIII Rule 12.

Everything outside these two categories is outside the CECP scope under Article 54(1). A Class III non-implantable device is not in CECP scope. A Class IIb active device that does not administer or remove a medicinal product is not in CECP scope. A Class IIa device is not in CECP scope.

Article 54(2) then carves out further exclusions from within the in-scope categories. These include certain certificate renewals, devices fully covered by common specifications published under Article 9, and certain certificate modifications where the clinical evidence base is unchanged. The exclusions must be confirmed by reading the current consolidated text of Article 54(2) for the specific device and the specific certification event — the text is specific and the interpretation is not something to carry in memory.

What this means for startup planning: the first question is whether the device meets the Article 54(1) scope definition for the device type. The second question is whether any Article 54(2) exclusion applies. The answer to both is a documented scope analysis in the regulatory strategy, not an assumption.

The expert panel and its role under Article 106

The expert panels are designated by the Commission in consultation with the MDCG under Article 106. Panels are organised by medical field — cardiovascular, neurology, orthopaedics, respiratory, endocrinology, general surgery, ophthalmology, and others — and members are selected based on demonstrated scientific and clinical expertise, absence of conflicts of interest, and independence from any single manufacturer.

For the CECP, the Commission forwards the notified body's clinical evaluation assessment report and the relevant clinical evaluation documentation to the relevant expert panel. The panel first decides whether to provide a scientific opinion at all. Where the panel decides to provide an opinion, it has a defined period in which to do so, set out in Annex IX Section 5.1 and the procedural rules of the panel.

The opinion addresses the sufficiency of the clinical evidence with respect to the intended purpose, the benefit-risk determination, the clinical investigation plan or the justification for relying on alternative sources under Annex XIV Part A and MDCG 2023-7, and the consistency of the clinical evaluation with Annex I general safety and performance requirements. The panel does not re-run the clinical evaluation. It reviews the package, identifies scientific concerns, and expresses its view.

The opinion then goes back to the notified body, which under Article 54(1) must give due consideration to it. In practice, the notified body either aligns its certification decision with the opinion, or documents a reasoned deviation — and in either case, the manufacturer needs to respond to any concerns the panel raised before a certificate is issued.

A worked timeline — what CECP looks like in the real world

For a Class III implantable device, the CECP adds a stage to the conformity assessment timeline that startups routinely under-plan. A realistic sequencing, starting from the point where the manufacturer's clinical evaluation is complete:

  • Weeks 0–8: Notified body review of the clinical evaluation, the CER, and the underlying clinical data. The notified body forms its own clinical evaluation assessment.
  • Week 8–12: Notified body drafts the clinical evaluation assessment report required by Article 54(1) and Annex IX Section 5.1. Internal notified body review of the report.
  • Week 12: Submission of the CECP package — notified body assessment report plus manufacturer clinical evaluation and the Annex II Sections 6.1(c) and (d) documentation — to the Commission.
  • Weeks 12–14: Commission forwards the package to the relevant expert panel. Panel decides whether to provide a scientific opinion.
  • Weeks 14–22 (if opinion is provided): Expert panel review and drafting of the scientific opinion within the procedural timeframe.
  • Weeks 22–26: Notified body integrates the scientific opinion, raises any additional questions to the manufacturer, and the manufacturer responds with CER amendments or clarifications where needed.
  • Weeks 26–30: Notified body finalises the certification decision, giving due consideration to the panel opinion, and documents any deviation.

These are not regulatory deadlines in every case — some of the internal notified body and manufacturer response times are determined by notified body capacity and manufacturer readiness, not by Article 54 itself. But the shape is stable: plan for the CECP as a distinct phase, not a line item that disappears into the notified body review.

Ship — the CER readiness playbook for CECP

Subtracted to its essentials, a CER that is ready for the CECP has seven properties. Each one is something you can check before the clinical evaluation is handed to the notified body.

  1. The intended purpose is explicit, narrow, and clinically precise. Every clinical claim in the CER is traceable to one sentence in the intended purpose. A CER that covers claims the intended purpose does not make — or that is silent on claims the intended purpose does make — will not survive an expert panel review.
  2. The benefit-risk determination under Annex I Sections 1 and 8 is written as an argument, not as a declaration. The CER explains which benefits, to which patient population, at what risk level, measured how, and why the benefits outweigh the risks. An expert panel reads this section first.
  3. The clinical data sources are mapped to Annex XIV Part A. Every source — literature, equivalence under MDCG 2020-5, clinical investigations, registries, non-interventional studies, post-market clinical follow-up — is identified, appraised, and analysed using the criteria Annex XIV Part A lays out. Any reliance on the Article 61(4) to (6) exemption routes under MDCG 2023-7 is documented against the specific exemption case.
  4. The clinical investigation evidence, where present, is reported against EN ISO 14155:2020+A11:2024. The clinical investigation design, conduct, and reporting align with the Good Clinical Practice requirements of the standard, and the investigation report cross-references the relevant sections.
  5. The risk management file under EN ISO 14971:2019+A11:2021 and the CER are consistent. Risks identified in the risk management file that have a clinical dimension appear in the CER, and the residual risk acceptability argument in the CER matches the risk management conclusions. Inconsistencies between these two documents are one of the most common expert panel findings.
  6. Gaps are named, not hidden. A CER that acknowledges specific residual uncertainties and explains how post-market clinical follow-up under Annex XIV Part B will address them is far stronger than a CER that claims completeness it cannot defend. The expert panel will find the gaps regardless — the only question is whether the manufacturer found them first.
  7. The document is readable. An expert panel member will read the CER once, often at speed. A CER that is logically ordered, cross-referenced, and written so that a specialist unfamiliar with the device can follow the clinical argument on a first read is a CER the panel can accept without sending back a list of clarifications.

This is not a shortcut. It is the CER discipline that makes the CECP a procedural step rather than a months-long re-opening of the clinical evidence strategy.

Reality Check — Where do you stand?

  1. Have you confirmed, by reading Article 54(1) and Article 54(2) against your device's specific classification under Annex VIII, whether your device is in CECP scope?
  2. Is your clinical evaluation assessment package — CER, clinical evaluation plan, clinical investigation reports, risk management summary — written so that an expert panel seeing it for the first time could reach a clear conclusion without asking clarifying questions?
  3. Have you mapped the CECP as a distinct phase in your certification timeline, separate from notified body review, with realistic internal and external durations?
  4. Have you identified the relevant expert panel medical field for your device, and read the procedural rules and the scope of opinions that panel has issued on comparable devices?
  5. Does your benefit-risk determination under Annex I Sections 1 and 8 stand up to an independent read, or does it rely on assumptions that only make sense if the reader has already been briefed by the manufacturer?
  6. Are your clinical evaluation and risk management file consistent, with every clinical risk traceable between the two documents?
  7. If the expert panel raises a concern, do you have a response plan — CER amendment capacity, additional analysis capacity, or contingency PMCF design — that does not blow your timeline?

Frequently Asked Questions

Is the CECP the same as the Article 55 scrutiny procedure? No. Article 54 defines the clinical evaluation consultation procedure, which is a pre-certification scientific consultation by an EU expert panel on the clinical evidence for certain Class III implantable and Class IIb active drug-delivery devices. Article 55 is a separate provision concerning information flow and transparency on certain certification decisions. They are adjacent in the MDR text and both involve EU-level visibility, but they serve different purposes and have different procedural mechanics.

Which devices are in scope for the CECP under MDR Article 54? Under Article 54(1), the CECP applies to Class III implantable devices and to Class IIb active devices intended to administer or remove a medicinal product as referred to under Annex VIII Rule 12. Article 54(2) then carves out specific exclusions including certain certificate renewals, devices fully covered by common specifications published under Article 9, and certain certificate modifications. The scope determination for a specific device must be made by reading the current consolidated text of Article 54 against the device's classification.

Is the expert panel's scientific opinion binding on the notified body? Not in the formal sense of a veto. Article 54(1) requires the notified body to give due consideration to the views expressed in the scientific opinion and to document its reasoning in the certification decision. In practice, deviating from a panel opinion that raises substantive scientific concerns is difficult without addressing those concerns in the clinical evidence package, which means the opinion functions as a strong steer even though it is not a formal approval gate.

Who submits the CECP package — the manufacturer or the notified body? The notified body. Under Article 54(1), following a positive assessment of the manufacturer's clinical evaluation, the notified body draws up its own clinical evaluation assessment report and submits it, together with the manufacturer's clinical evaluation and the documentation referred to in Annex II Sections 6.1(c) and (d), to the Commission, which forwards the package to the expert panel designated under Article 106.

How much does the CECP add to the certification timeline for a Class III implantable device? Realistically, plan for an additional phase of several weeks to several months on top of the standard notified body review, depending on whether the expert panel decides to provide an opinion and how substantive any findings are. The CECP is not a line item that disappears into notified body review — it is a distinct phase with its own internal logic, and the safest planning assumption is to treat it as such from the start of the regulatory strategy.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 54 (clinical evaluation consultation procedure), Article 54(1) (scope and procedural basis), Article 54(2) (exclusions), Article 55 (information on certain certification decisions), Article 106 (expert panels and expert laboratories), Annex IX Section 5.1 (procedural detail of the clinical evaluation assessment report), Annex XIV Part A (clinical evaluation procedure), Annex VIII (classification rules including Rule 12), Annex II Sections 6.1(c) and (d) (technical documentation on clinical evaluation). Official Journal L 117, 5.5.2017.
  2. MDCG 2020-5 — Clinical Evaluation — Equivalence: A guide for manufacturers and notified bodies, April 2020.
  3. MDCG 2023-7 — Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on 'sufficient levels of access' to data needed to justify claims of equivalence, December 2023.
  4. EN ISO 14155:2020+A11:2024 — Clinical investigation of medical devices for human subjects — Good clinical practice.
  5. EN ISO 14971:2019+A11:2021 — Medical devices — Application of risk management to medical devices.

This post is part of the Clinical Evaluation & Clinical Investigations series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. If your device is in scope for the CECP under Article 54 and your clinical evaluation has not yet been stress-tested against an independent expert panel read, Zechmeister Strategic Solutions works with founders on exactly this — building a CER that survives the CECP as a procedural step rather than a months-long re-opening of the clinical evidence strategy.