CECP Procedure: What Should Medical Device Manufacturers Watch Out For?

News

24 June 2025

1. CECP: A Tough Filter for Clinically Weak Dossiers

Regulation (EU) 2017/745 on medical devices (MDR) introduced a procedure that remains poorly understood by many manufacturers: the Clinical Evaluation Consultation Procedure, or CECP.

This procedure applies to certain high-risk medical devices, including:

Class III implantable devices,
Class IIb devices that administer or remove medicinal substances (e.g., pumps, injectors, ventilators).

As soon as a device falls within this scope, the MDR requires that an independent panel of experts be consulted to provide a scientific opinion on the robustness of the clinical evidence.

But beware: these experts do not review the manufacturer’s Clinical Evaluation Report (CER). They assess the Clinical Evaluation Assessment Report (CEAR) prepared by the Notified Body (NB). And their mission is not to be lenient.

Real-World Example: The CECP Opinion of June 24, 2025

On June 24, 2025, the European Commission published a particularly harsh scientific opinion concerning a mechanical ventilator intended for both adult and pediatric patients.

The device, submitted for CE marking by a Notified Body (NB 2696), triggered the CECP process. The expert panel issued a strongly critical opinion, pointing out major flaws in the file: inconsistencies across documents, questionable clinical claims, a poorly designed PMCF plan, and more.

An Underestimated Mechanism In practice, many manufacturers — and even some Notified Bodies — underestimate the level of scrutiny applied by these expert panels.

It’s easy to think that ticking the regulatory boxes or submitting a nicely formatted CER will suffice. But the CECP functions as a clinical credibility check: it tests the overall coherence and seriousness of the file, including how diligently the NB has performed its evaluation.

And when the expected level isn’t met? This isn’t just a comment in passing — it can completely block the CE certification process.

2. What Is the CECP (Clinical Evaluation Consultation Procedure)?

The CECP procedure for medical devices, introduced in Article 54 of the MDR, is a mandatory and strategically significant step in the clinical evaluation of high-risk devices. It involves a panel of independent experts appointed by the European Commission, who are tasked with providing a scientific opinion on the clinical evaluation performed by the Notified Body.

When Does the CECP Apply?

The CECP only applies to a subset of high-risk medical devices. It is mandatory for:

Class III implantable devices, unless exempted (e.g., well-established devices, equivalents already marketed by the same manufacturer),
Class IIb devices designed to:
Administer medicinal products or substances of human origin,
Remove substances from the human body (e.g., dialyzers, extracorporeal oxygenation systems).

Important: the CECP is not initiated by the manufacturer, but by the Notified Body once it has completed its clinical evaluation and determined that the device falls within the scope of Article 54.

Who Does What? Manufacturer, Notified Body, Expert Panel

The manufacturer prepares the Clinical Evaluation Report (CER) — a key document compiling clinical data to demonstrate the device’s safety and performance for its intended purpose.
The Notified Body (NB) reviews the CER, compares it against the Clinical Evaluation Plan (CEP) and any available PMCF data, then prepares its own internal analysis: the Clinical Evaluation Assessment Report (CEAR).
The expert panel only reviews the CEAR — not the CER. Their mission: to evaluate the scientific rigor of the NB’s assessment and flag any concerns about the benefit-risk conclusion if it appears insufficient, inconsistent, or unsupported.

What the Panel Actually Evaluates: The CEAR, Not the CER

This is often misunderstood: the panel does not directly assess the manufacturer’s clinical evidence. Instead, they assess how well the Notified Body interpreted and judged that evidence.

Put differently: if your file is weak, unclear, poorly structured, or contradictory, the NB may overlook critical issues… And that’s where the panel steps in to sound the alarm.

It’s not just the data that’s being evaluated — it’s the quality of the clinical judgment applied. And that can challenge the validity of the entire conformity assessment process.

3. Case Study: A Ventilator Rejected Through the CECP (June 2025)

On June 24, 2025, the European Commission published a particularly critical scientific opinion following a CECP procedure regarding a mechanical ventilator intended for adult and pediatric patients. This real-world case clearly illustrates the expectations — and the high standards — of expert panels under the MDR.

Context of the Device Under Review

The device in question was a Class IIb ventilator, intended to provide artificial respiratory support in cases of respiratory failure. The manufacturer specified hospital use, including for children starting from 1 kg.

The CE marking application was submitted to Notified Body no. 2696 in October 2024. Due to the risk level and novelty of the device, a CECP consultation was triggered, as required under Article 54 of the MDR.

Why the CECP Was Triggered

Three key elements led the expert panel to deliver a formal opinion:

1. The device was new to the market, with no established clinical background.

2. The Notified Body’s CEAR contained major inconsistencies.

3. There was a potentially significant risk to patient safety, based on unresolved uncertainties.

The 7 Key Issues Identified by the Expert Panel

The CECP opinion highlighted several critical weaknesses — all examples of what not to do in a clinical evaluation for a high-risk medical device:

1. Inconsistent device name

The device was referred to as AirVENT60 in the CEAR and Vent 2 in the CER. No justification was provided. A basic inconsistency — but already problematic.

2. Poorly defined target population

The CEAR listed patients >5 kg; the CER mentioned >1 kg (with tidal volumes of 10 ml). Experts noted that tidal volumes >50 ml are not suitable for neonates or most infants.

3. Incomplete intended use description

The CEAR specified use via mask or tracheostomy, but made no mention of endotracheal intubation — a common ventilation method.

4. Incorrect clinical claim

The CEAR stated that the device “reduces intracranial pressure”. Experts noted that in most cases, mechanical ventilation increases this pressure — except in very specific circumstances.

5. Unsafe oxygen use instructions

The CER advised cutting oxygen supply before interrupting ventilation, followed by several ventilation cycles without oxygen. Experts deemed this unsafe and unrealistic in standard clinical scenarios.

6. Contradictory PMCF plan

The PMCF planned to include outpatients (e.g. sleep clinics), while excluding intubated or tracheostomized patients — yet other documents defined the device’s use as hospital-only. Clear contradiction.

7. Poor-quality documentation

Figures in the file were unclear, difficult to read, and sometimes inconsistent, making interpretation challenging.

What This Reveals About the Level of Scrutiny

This opinion highlights a fundamental expectation: Clinical consistency and traceability are non-negotiable.

The panel wasn’t hunting for legal loopholes or missing signatures — they were flagging factual, clinical, and technical contradictions across the documentation.

They expect:

a clear understanding of the device’s intended purpose,
a robust clinical logic,
and tight alignment between the CER, PMCF, intended use, and all supporting documents.

This case also shows that the panel may apply stricter scrutiny than the Notified Body itself. The CEAR had been reviewed and submitted… but didn’t survive expert review.

4. Manufacturer Checklist: What Should You Watch Out For?

When your device falls within the scope of the CECP, the key question is no longer: “Is my file complete?”

But rather: “Will it stand up to an independent, rigorous, and unforgiving clinical review?”

The good news is that most pitfalls can be avoided — if addressed early. Here’s what every medical device manufacturer should pay close attention to when preparing for the CECP process.

What You Must Absolutely Anticipate

1. Ensure complete consistency across documents

Your CER, Clinical Evaluation Plan (CEP), PMCF plan, IFU, and SSCP must tell a coherent story. Discrepancies in product name, intended use, or target population — even minor ones — can seriously damage credibility.

2. Clearly define your indications, target population, and modes of use

No room for vagueness: patient age and weight, method of administration, care setting (hospital, home…) — everything must be explicitly described and justified.

3. Don’t overstate clinical benefits

It’s tempting to make strong claims to reassure the NB and boost the perceived value of your product. But stating that a device “reduces intracranial pressure” without solid evidence is not just risky — it’s scientifically unsound and ethically questionable.

4. Prepare a credible, targeted PMCF plan

A generic PMCF plan that has no link to the actual clinical risks is not credible. It’s a checkbox exercise — and expert panels will spot it instantly. Ask yourself the real question: What still needs to be demonstrated after market launch?

5. Anticipate CECP logic from the CER stage onward

Even though the panel only reads the CEAR, your CER should be built as if it were a defensible, traceable, and audit-ready document. Each claim must be backed by evidence, each method justified, each link to residual risk documented.

6. Don’t hesitate to challenge your Notified Body

The CEAR is written by the NB — but you have the right to review it, or at least ask for clarification about its contents. A Notified Body that tolerates clinical vagueness is not doing you a favor.

Do / Don’t – The CECP Reflex Table

✅ Do	❌ Don’t
Harmonize indications and target population across all documents	Use different terms depending on the document
Clearly define inclusion/exclusion thresholds	Be vague about the patient population
Justify every clinical claim with evidence	Make unsupported benefit claims
Build a PMCF plan tailored to your device risks	Copy-paste a generic PMCF template
Anticipate CECP-level scrutiny from the CER stage	Assume your NB will “filter out” any inconsistencies
Ask questions about the CEAR content	Discover the panel’s concerns too late

The CECP is not a trap set by regulators. It’s an objective stress test — one that reveals the weaknesses that could otherwise remain hidden… until they surface as post-market incidents.

5. Case Studies: Two CECP Outcomes, Two Very Different Stories

To truly understand the impact of the CECP process, nothing beats a real-world scenario. Here are two common cases we encounter when supporting manufacturers — one shows how to proactively align with CECP expectations, the other illustrates how even a “nice” Notified Body won’t shield you from a weak dossier.

✅ Case #1: A Solid Dossier That Passed CECP Smoothly

Device: Implantable intestinal motility stimulator (Class III)

Manufacturer: French SME undergoing its first CE marking under MDR

What they did right:

The CEP laid out a clear, tailored clinical strategy from the start, based on targeted literature and a relevant pilot study.
The target population was well defined: adults aged 18–75, with reproducible inclusion/exclusion criteria.
The CER was well-structured and aligned with the CEP.
The PMCF plan included a five-year multicenter registry — budgeted and scheduled in advance.
The Notified Body was involved early in CECP planning, and the manufacturer reviewed and discussed the CEAR before it was submitted to the panel.

Outcome: The CECP opinion included minor suggestions on the PMCF plan — but no critical issues. The NB issued the certificate without delay.

❌ Case #2: A Vague Dossier Blocked by the Panel

Device: Portable ozone generator for infected wounds (Class IIb)

Manufacturer: European start-up with a background in cosmetics

What went wrong:

The CEP was a generic template, with no customization or alignment to the actual device.
The CER relied on aquatic ozone studies (!) to support claims in wound healing.
The PMCF was a vague patient satisfaction survey — to be defined later.
The Notified Body, under pressure, accepted a superficial CEAR without challenging the assumptions.
The device name varied across documents, and indications differed by language version.

Outcome: The CECP panel issued a negative opinion, citing major methodological flaws, lack of relevant clinical data, and a disconnected PMCF plan. The NB had to suspend the assessment and send the file back to the manufacturer.

In both cases, the deciding factor wasn’t the size of the company or the perceived “value” of the device. It came down to documentation quality, anticipation of expectations, and the manufacturer’s ability to challenge — and be challenged by — their NB.

6. Mini FAQ – What You (Really) Need to Know About the CECP

When is the CECP mandatory?

The Clinical Evaluation Consultation Procedure (CECP) is mandatory for:

Class III implantable devices, unless exempted under MDR Article 54;
Class IIb devices intended to administer or remove a medicinal product, substance, or fluid from the human body.

It’s not the manufacturer who initiates the CECP — the Notified Body does, once it has completed the clinical evaluation and confirmed the device falls within the scope.

Can manufacturers communicate directly with the expert panel?

No — direct communication is not allowed. The panel works exclusively from the CEAR (Clinical Evaluation Assessment Report) provided by the Notified Body, and sometimes annexes like the CER or PMCF plan.

The exchange occurs only between the panel and the Notified Body. Manufacturers have no access to internal deliberations.

Does a negative CECP opinion automatically block CE marking?

Not necessarily. The panel’s opinion is non-binding, but highly influential.

If the panel raises serious concerns, the Notified Body may:

Follow the recommendations,
Or disregard them — but only if it provides detailed scientific justification in the final report (Annex IX, Section 5.1.g).

In practice, a negative CECP opinion will heavily complicate the CE certification process.

What if the Notified Body chooses not to follow the panel’s advice?

It’s allowed — but only if the NB provides a robust, documented rationale. And that justification will be closely scrutinized during audits or by regulators.

This is not a light decision. An NB that disregards a CECP opinion risks non-conformity, or even loss of designation if it cannot defend its reasoning.

How should a manufacturer prepare for the CECP?

Anticipate CECP requirements from the clinical planning stage (CEP).
Draft a CER that’s structured, consistent, and evidence-based.
Build a targeted PMCF plan linked to real residual risks.
Ensure full coherence across all documentation (device name, indications, target population…).
Engage with your NB and challenge the CEAR content before submission.

And above all: Even if you don’t attend the panel review… your clinical work will.

7. Conclusion – The CECP Isn’t a Sanction. It’s a Stress Test.

Often perceived as a threat or a bureaucratic burden, the Clinical Evaluation Consultation Procedure (CECP) is neither punitive nor arbitrary. It plays a clear and legitimate role within the MDR framework: testing the clinical robustness of a device when patient risk is highest.

In that sense, the CECP acts as a regulatory stress test. It doesn’t just check whether you’ve submitted a CER or a PMCF plan — it assesses whether those elements are coherent, credible, and clinically meaningful.

A Chance to Stand Out for the Right Reasons

For serious, well-prepared manufacturers, the CECP can become a legitimacy booster:

It forces you to build a coherent and well-documented clinical strategy.
It allows structured, evidence-based discussions with your Notified Body.
It strengthens the long-term credibility of your device — including in audits or outside the EU.

In other words, it’s not the CECP that puts manufacturers at risk. It’s the approximations, the inconsistencies, and the weak clinical justifications that come back to haunt them.

8. Need a Clinical File That Holds Up Under CECP Scrutiny?

Are you developing a medical device subject to the CECP procedure? You already know your Notified Body won’t be able to fix everything — and that every inconsistency in your clinical documentation will be exposed.

At CSDmed, we support manufacturers from the earliest stages to:

Build a clinical strategy aligned with MDR expectations,
Draft a robust and coherent CER that can withstand external review,
Develop a tailored PMCF plan, based on actual risk and market strategy,
And engage constructively with your Notified Body — before the panel delivers its verdict.

A well-prepared file has nothing to fear from the CECP. But it doesn’t come together by accident.

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