Clinical evaluation without pitfalls — the practice-oriented checklist for MDR

This blog post will explain the key questions that an MDR-compliant clinical evaluation must answer, from the precise definition of the intended purpose to the design of a robust Clinical Evaluation Plan (CEP), the selection and evaluation of suitable clinical data sources and the choice of the right evaluation route, to the systematic integration of PMS/PMCF data, reproducible literature research, measurable formulation of claims and active lifecycle management of the CER. 

Abbreviations

CEP	Clinical evaluation plan
CERIUM	Clinical Evaluation Report
CIP	Clinical Investigation Plan
MDR	Medical Device Regulation (EU Ordinance 2017/745)
TD	Technical Documentation
Pmcf	Post-Market Clinical Follow-up
Pms	Post-Market Surveillance

Underlying regulations, standards and guidelines

EU Regulation 2017/745 (MDR)

MDCG 2020-1

MDCG 2020-5

MDCG 2020-6

MEDDEV Guideline 2.7/1 Revision 4

Draft of ISO/DIS 18969

1 Introduction

Under the MDR, clinical evaluation is not simply an item on a to-do list to be completed and filed away. It is the central, dynamic instrument for ensuring the safety, performance, and clinical benefit of a product throughout its entire life cycle, and therefore a key point of review for notified bodies and regulatory authorities.

This blog post provides you with a manageable structure: a concise overview of the most important review and decision-making areas, linked to practical tips, quick checks, and requirements. Use it as a work guide: review, document, and fill in any gaps.

2. Practical guide to clinical evaluation

2.1 Everything begins with the intended purpose

Every clinical evaluation begins with a precise definition of the intended purpose. This is not just a formal slogan, but the benchmark against which the entire evidence strategy is measured: What clinical data do you need? Which patient group is affected? In what application context (indications, users, setting, duration of use) is the product used? Only when the intended purpose, information requirements (IFU), marketing materials, and clinical evaluation guidelines (CER) speak the same, unambiguous language can claims or endpoints be meaningfully substantiated. A common mistake is an overly broad or inconsistent intended purpose: this leads directly to contradictory data requirements, vague claims/endpoints, and avoidable audit findings. Therefore, first check whether the intended purpose is formulated identically in the CEP, CER, IFU, and other documents, and consistently correct any discrepancies.

2.2 The CEP is the timetable

Clinical evaluation doesn't begin with the Clinical Evaluation Report (CER), but with the Clinical Evaluation Plan (CEP). A robust CEP defines how you intend to demonstrate clinical safety and performance: It includes a description of the product and its intended purpose, precisely formulated claims and measurable endpoints, the planned data sources (in-house studies, literature, PMS/PMCF, equivalence data), the evaluation and analysis methodology, and an update and trigger strategy for CER revisions. Without this guidance, your CER will be reactive, incomplete, and difficult to defend.

2.3 What really counts as a clinical data basis?

“We have clinical data” is not a sufficient statement. The quality, relevance, evidence, and origin of the data are crucial.

Under the MDR, this primarily includes clinical trials with the product itself, systematically evaluated scientific literature on the product, structured PMS and PMCF data, and, only under strict conditions, equivalence data. Crucially, you must clearly document for each data source used why it is suitable for answering your claims.

2.4 Choosing the right route — strategically and with justification

One of the most important strategic decisions is the choice of evidence route: proprietary clinical data, equivalence, or performance/verification-based argumentation according to Article 61(10). Proprietary clinical data often provide the strongest methodological foundation. The equivalence route remains possible but has become considerably more difficult: technical, biological, and clinical similarity must be demonstrated in detail and verifiably; furthermore, you need access to the underlying data. The performance route can be appropriate for less risky, non-invasive products but requires a sound, rational justification for why clinical data are not necessary. Therefore, specify the chosen route in the CEP (Commissioned Evaluation Process).

2.5 State of the Art as a benchmark

The State-of-the-Art (SotA) chapter in the CER must not simply be a compilation of studies. It must function as a benchmark: medical SotA (guidelines, best available therapies, expected clinical outcomes) and technical SotA (comparable technologies and performance standards) must be analyzed separately. From this analysis, you derive quantifiable reference values, complication rates, measurement accuracies, and performance ranges against which your product is positioned. In this way, the SotA analysis becomes the basis for realistic, verifiable claims and simultaneously reveals where evidence gaps exist and which PMCF (Product Life Cycle Criteria) questions should be prioritized.

2.6 Literature review: systematic, reproducible, verifiable

A proper literature search is both plannable and reproducible. A predefined search plan with inclusion and exclusion criteria, databases, search strings, and timeframes is essential. Subsequently, the screening process must be transparently documented in a search log (title/abstract → full text), and the critical evaluation (bias, relevance of endpoints) must be traceable. Without this systematic approach, the literature search is not verifiable.

2.7 Claims: measurable, traceable, linked

Clinical claims are not advertising slogans; they must be objectively measurable. Categorize claims into safety, performance, and benefit claims, and for each claim, provide a claim ID, a precise formulation, and a measurable endpoint. Link claims in a traceability matrix to their corresponding endpoints and supporting evidence. This is the only way to prevent discrepancies between IFU statements, marketing messages, and CER claims—a classic reason for audit findings.

2.8 PMS and PMCF: the engines of the CER lifecycle

PMS and PMCF are two sides of the same evidence loop: PMS continuously collects feedback from the field (vigilance, complaints, trend data), PMCF specifically provides clinical answers to open questions and fills evidence gaps that may have existed at the time of CE marking or that may have arisen over time.

Together they keep the CER “alive”, PMCF data confirm or refine claims, provide reliable incidence rates and drive benefit-risk reassessments; PMS trends show where PMCF is needed at all.

In short: PMS shows what happens; PMCF explains why and how strongly; the CER is where these findings are versioned, justified and translated into action.

2.9 CERR lifecycle: check regularly, update immediately if necessary

The MDR does not require a rigid review schedule for all products, but it does stipulate that CERs must be actively maintained. For Class III and implantable products, an annual update is explicitly required; for other classes, a risk-based approach with regular reviews applies (often every 2–3 years for Class IIa/IIb, and for Class I at least at an appropriate interval, e.g., up to 5 years, or sooner if relevant signals emerge). Crucially, in addition to periodic reviews, clearly defined triggers must exist: PMS trends, changes to the product or product family, or new risks.

2.10 Consistency in documentation: CER, IFU, RMF and marketing in harmony

Inconsistencies between the CER, IFU, Risk Management File, PMS, and marketing are among the most frequent audit findings. Therefore, conduct systematic consistency checks: Verdict and consistency of purpose across all documents; agreement between the risks identified as clinically relevant in the RMF and the risks discussed in the CER; and a clear mapping of all IFU references to data supported by the CER. Marketing claims may only be used if they are linked to an explicit, documented chain of evidence.

2.11 Practical Quick Checks

Before you release a document, you should keep the following points in mind:

✔ Is the intended purpose consistent?

✔ Does a final CEP exist with clear claims and measurable parameters?

✔ Is a reproducible literature search protocol available?

✔ And lastly: Is every revision versioned, justified, and technically approved?

3. Conclusion

A robust, MDR-compliant clinical evaluation is not achieved solely through lengthy reports, but through rigorous planning (CEP), methodological diligence (reproducible literature search, clean data specification), ongoing real-world evidence (PMS/PMCF) and complete traceability.

4. How we can help you

We provide pragmatic support throughout the entire clinical evaluation lifecycle—from strategic planning to audit-ready documentation. Our goal is to design your CER processes to be MDR-compliant, methodologically sound, and practically applicable. We combine regulatory expertise with practical project and study know-how to transform requirements into genuine, defensible evidence.

Specifically, we can support you with, for example:

• Gap analyses of your existing CEP/CER/PMCF documentation, including prioritized action planning.
• Creation and review of CEPs and CERs.
• Methodology decision & study design: We define endpoints, populations, statistical plans and monitoring concepts for clinical trials or PMCF studies.
• Literature review & evidence appraisal: systematic search, quality assessment and integration into the benefit-risk analysis.
• PMCF conception and implementation.

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