EU MDR · Class III · CECP
The Clinical Evaluation Consultation Procedure, explained by former reviewers.
For high-risk devices, an independent EU expert panel gets a say before your Notified Body can certify. Know when the CECP applies, how the panel thinks, and how to prepare clinical data that survives it.
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Led by authority
Reviewed by people who sat on the panel side.
The CECP is a panel of independent experts. The best preparation is guidance from clinicians who have reviewed high-risk devices at a Notified Body.
Dr Mark DaCosta
Former lead Notified Body reviewer at TÜV SÜD. 400+ devices CE-certified, including Class III implantables.
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Pierre-Marie Boutanquoi
CERs under MEDDEV 2.7/1 Rev 4 and EU MDR, and Notified Body deficiency response for high-risk devices.
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Europe’s best-rated medical device CRO.
Platinum Award 2026
Top tier at the xShare × EUCROF Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at EUCROF 2026 in Amsterdam.
The announcement →Co-funded by the European Union
Selected through the xShare Open Call for clinical research innovation, Horizon Europe.
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CVBF coverage →The procedure
From the legal trigger to a panel-ready dossier.
EU MDR 2017/745 came into force on 26 May 2021 and raised the bar for clinical and post-market data. One of its most consequential additions is the Clinical Evaluation Consultation Procedure — an extra level of scrutiny for the highest-risk devices.
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What the CECP is and why it exists
The CECP ensures Notified Bodies accurately assess the quantity and quality of clinical data before certifying certain high-risk devices. For eligible devices, the Notified Body must submit its clinical evaluation assessment report to an independent EU expert panel, coordinated by the European Medicines Agency (EMA), which can issue a scientific opinion the Notified Body must give due consideration to.
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Which devices trigger it
Under Article 54, the procedure applies to two groups.
In scope
- Class III implantable devices
- Class IIb active devices intended to administer and/or remove a medicinal product
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The process and timelines
The EMA supervises ten expert panels, each specialising in a medical field such as cardiovascular or orthopaedics. When the Notified Body submits its report, the screening panel decides within 21 days whether a full consultation is needed. If it is, the expert panel delivers a scientific opinion within 60 days, examining the novelty of the device, changes to the benefit-risk profile, and any significant increase in serious incidents. These clocks run on top of the Notified Body assessment and must be built into your CE-marking schedule.
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Exemptions under Article 52(2) and MDCG 2019-3
Not every eligible device goes through a full consultation. Three criteria can exempt a device.
Exemption criteria
- Certificate renewal — devices already holding a certificate issued under the MDR may be exempt
- Unchanged benefit-risk profile — a modification to an already-marketed device with the same intended purpose that does not negatively affect benefit-risk
- Common specifications — where the Notified Body confirms compliance with the relevant applicable common specifications for the device’s clinical evaluation
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What the track record tells us
Article 52(4) requires the European Commission to publish an annual overview. The first, published in January 2023, covered April 2021 to June 2022: eight Notified Bodies submitted 215 notifications under Article 54(3), and the CECP was actually requested in only 24 cases. All scientific opinions are public. In the published opinions to date, expert panels have consistently diverged from the Notified Body’s assessment of the clinical data — a clear signal that panels expect more, and better, evidence.
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How to prepare
The recurring theme in published opinions is inadequate pre-market clinical data. The defence is not paperwork, it is evidence: a clinical evaluation report built the way panels expect, with pre-market data and PMCF planned to close every gap before the panel finds it. Our former Notified Body reviewers pressure-test the dossier against the exact questions a panel asks.
The CECP in numbers
What the first annual overview showed.
Talk to a reviewer
Is your Class III or Class IIb device CECP-ready?
Book a free strategy call with a clinician and a former Notified Body reviewer. We tell you whether the CECP applies, where a panel would push back, and how to close the gaps before submission.
Book a free strategy callDon’t let an expert panel be the first to read your evidence critically.
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