What must a CEP specify regarding equivalence claims?

If the manufacturer intends to rely on clinical data from an equivalent device rather than generating all evidence from its own device, the CEP must identify the equivalence claim and outline how technical, biological, and clinical equivalence will be demonstrated per MDR Annex XIV. This upfront commitment matters because Notified Bodies scrutinize equivalence claims heavily, and a CEP that leaves the equivalence rationale vague is a frequent source of clinical evaluation deficiencies.

Why is a weak or generic CEP such a common deficiency in MDR reviews?

A generic CEP that does not clearly define device-specific acceptance criteria, data sources, or a benefit-risk methodology gives the Notified Body nothing concrete to assess the CER against, which often surfaces as a nonconformity even if the CER itself contains reasonable data. Manufacturers sometimes reuse a templated CEP across multiple device families without tailoring it to the specific intended purpose, patient population, and known risks of each device, which is precisely what MDCG 2020-13 scoring is designed to catch.

Does the CEP need to address post-market clinical follow-up?

Yes, the CEP must include the plan for ongoing clinical evaluation through Post-Market Clinical Follow-up (PMCF), since MDR treats clinical evaluation as a continuous lifecycle activity rather than a one-time premarket exercise. A CEP that only addresses premarket evidence generation without describing how PMCF data will be collected and fed back into the clinical evaluation is incomplete under Annex XIV.

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Clinical Evaluation Plan

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).

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

Definition

A Clinical Evaluation Plan (CEP) is a structured planning document required under EU MDR (Annex XIV Part A §1(a)) that defines how the manufacturer will conduct the clinical evaluation of a medical device. The CEP identifies the device and its intended purpose, the equivalence claim (if any), the clinical development stages, the data sources to be evaluated (clinical investigations, literature, post-market data), the acceptance criteria for clinical performance and safety, the benefit-risk methodology, and the plan for ongoing clinical evaluation through PMCF. The CER documents the execution of the CEP.

What the regulation says

EU MDR Annex XIV Part A §1(a) requires a CEP. MDCG 2020-13 (Clinical evaluation assessment report template) is what Notified Bodies use to evaluate the CER against the CEP. For legacy devices, MDCG 2020-6 provides guidance on clinical evidence for legacy devices.

What this means in practice

Under MDR, the CEP is the upfront commitment that disciplines the entire clinical evaluation process, Notified Bodies review the CEP for adequacy before accepting a CER. A weak or generic CEP is one of the most common causes of MDR clinical evaluation deficiencies. MDCG 2020-13 provides the CER assessment template that Notified Bodies use, and it is essentially scoring CER conformance against the CEP.

Examples

A manufacturer drafted a CEP for a novel orthopedic implant, outlining the specific clinical data from pre-market studies and a plan for post-market clinical follow-up (PMCF) to demonstrate long-term safety and performance.
For a software as a medical device (SaMD) used for diagnostic support, the CEP detailed the literature review strategy, the specific clinical endpoints for performance, and the acceptance criteria for diagnostic accuracy and clinical utility.
The CEP for an existing cardiovascular device undergoing EU MDR re-certification focused on leveraging real-world data and a targeted clinical investigation to address identified gaps in clinical evidence against the new regulatory requirements.

Common pitfalls

•Writing a generic CEP that doesn't actually scope the clinical evaluation, Notified Bodies will issue major deficiencies.
•Skipping the equivalence rationale in the CEP and then claiming equivalence in the CER, must be planned upfront.
•Failing to align the CEP with the PMCF plan, they are intended to form a continuous evidence loop.

Frequently asked questions

The Clinical Evaluation Plan (CEP) is the upfront document that defines the scope, data sources, acceptance criteria, and methodology for the clinical evaluation before it is performed, required under EU MDR Annex XIV Part A. The Clinical Evaluation Report (CER) is the output document that reports the results of executing that plan. Notified Bodies specifically assess whether the CER's conclusions and methodology are consistent with what the CEP committed to upfront, using the MDCG 2020-13 assessment template.

Grouped by theme

Editor's picks

· Hand-selected related concepts

Post-Market

Post-Market Performance Follow-up(PMPF)

The IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification.

Clinical & Trials

Clinical Evaluation Report(CER)

Documented assessment of clinical data demonstrating EU MDR conformity for a device.

Clinical & Trials

Real-World Evidence(RWE)

Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data.

Standards

ISO 14155

Good clinical practice for clinical investigations of medical devices.

IVDR Essentials

· From this learning path

Regulatory

General Safety and Performance Requirements(GSPRs)

Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets.

Adjacent lesson

Regulatory

CE Mark

Mandatory European conformity mark for medical devices placed on the EU market.

Market Segments

Companion Diagnostic(CDx)

IVD that identifies patients who will benefit from a specific drug.

Regulatory

EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

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Category: Clinical & Trials
Acronym: CEP
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Updated: 6/20/2026

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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).

·Under MDR, the CEP is the upfront commitment that disciplines the entire clinical evaluation process, Notified Bodies review the CEP for adequacy before accepting a CER.
·A weak or generic CEP is one of the most common causes of MDR clinical evaluation deficiencies.
·MDCG 2020-13 provides the CER assessment template that Notified Bodies use, and it is essentially scoring CER conformance against the CEP.

Remember this

Watch out: Writing a generic CEP that doesn't actually scope the clinical evaluation, Notified Bodies will issue major deficiencies.

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