PMCF — the bridge from real-world data to the CER

This blog post explains the role of Post-Market Clinical Follow-Up (PMCF) as an integral part of Clinical Evaluation (CER), the relevant regulatory requirements, how to plan and conduct PMCF effectively, and how PMCF results are systematically integrated into CER, risk management, and the Instructions for Use (IFU) and labeling. We also provide practical guidance on suitable data sources, how to evaluate signals, and the organizational prerequisites for successful and audit-proof PMCF projects.

Abbreviations

Underlying regulations, standards and guidelines

EU Regulation 2017/745 (MDR)

MDCG 2020-7

MDCG 2020-8

1 Introduction

Post-Market Clinical Follow-Up (PMCF) is far more than simply collecting data retrospectively; it is a strategic, methodically driven tool that enables manufacturers to address specific open questions regarding the safety and clinical performance of a product. In light of the MDR (particularly Article 61, paragraph 11, and Annex XIV, Part B), PMCF is not optional but rather an integral part of the ongoing commitment to maintaining the Clinical Evaluation (CER) throughout the entire product lifecycle. PMCF provides the high-quality, prospectively collected clinical data necessary to support claims, substantiate benefit-risk analyses, and fill data gaps precisely where general post-market surveillance data (vigilance, symptoms) are insufficient.

PMCF should not be viewed in isolation, but rather as an integral, clinical component within the broader post-market surveillance (PMS) system. While PMS, as an "umbrella process," combines reactive (vigilance, complaints, FSCA) and proactive (user feedback) data, PMCF is the targeted, methodologically controlled activity that addresses the gaps left by non-clinical PMS data: PMCF provides the systematically collected clinical data to answer open questions and test specific hypotheses from the CER.

This close integration—PMS as a broad data collection tool and PMCF as a clinical review and closure function—creates a single evidence loop: Both provide directly usable inputs for clinical evaluation (CER), the risk management file (ISO 14971), and IFU/label adjustments. The result is a closed control loop: PMS detects signals, PMCF validates or refutes hypotheses with high methodological rigor, and the insights gained are fed back into benefit-risk analyses and claims assessments in the CER in an audit-proof manner. And all this with data from routine clinical practice…

2. Core requirements of the MDR

The MDR makes PMCF not an optional favor, but an integral, ongoing obligation: Article 61, paragraph 11, and Annex XIV, Part B, require that post-market clinical follow-up be methodically planned, continuously conducted, and its results systematically incorporated into the clinical evaluation (CER) and risk management. For manufacturers, this means specifically: PMCF is an ongoing process that confirms the safety and performance assumptions of a product throughout its expected lifespan, keeps residual risks verifiable, and identifies emerging risks.

Article 61 paragraph 11 of the MDR is a clear, practical mandate for manufacturers:

(11) The clinical evaluation and the accompanying documentation shall be updated throughout the product life cycle on the basis of the clinical data obtained from the implementation of the clinical follow-up plan in accordance with Part B of Annex XIV and the post-market surveillance plan in accordance with Article 84.

Annex XIV, Part B: Post-marketing clinical follow-up

5. Post-market clinical follow-up is understood as an ongoing process for updating the clinical evaluation in accordance with Article 61 and Part A of this Annex and is addressed in the manufacturer's post-market surveillance plan. In post-market clinical follow-up, the manufacturer proactively collects and evaluates clinical data arising from the use in or on the human body of a CE-marked product that has been placed on the market or put into service within the scope of its intended purpose in accordance with the relevant conformity assessment procedure, in order to confirm the safety and performance during the expected lifetime of the product, to ensure the continuing acceptability of the identified risks, and to identify emerging risks based on relevant evidence.

6. Post-marketing clinical follow-up will be according to a method set out in a post-marketing clinical follow-up plan.

…

7. The manufacturer analyzes the findings from post-market clinical follow-up and documents the results in a post-market clinical follow-up evaluation report; this report forms part of the clinical evaluation report and the technical documentation.

 8. The conclusions of the post-marketing clinical follow-up evaluation report are taken into account in the clinical evaluation pursuant to Article 61 and Part A of this Annex and in the risk management pursuant to Annex I, Section 3. If the post-marketing clinical follow-up identifies the need for preventive and/or corrective action, the manufacturer shall implement such action.

In practical terms, this means that questions for PMCF are derived directly from identified data gaps in the CER or from signals from the PMS, that a methodologically sound documented PMCF plan is available, and that the results are compiled in an evaluation report that is an integral part of the technical documentation.

Finally, the MDR requires that conclusions derived from PMCF results be incorporated into both the CER's benefit-risk analysis and the risk management file, and, if necessary, implemented in the form of preventive or corrective actions.

3. General and specific methods

PMCF employs a range of methods, selected and combined according to the research question, product characteristics, and feasibility. General methods include the structured collection of clinical experience from routine operations, such as hospital or outpatient data, as well as the systematic gathering of user feedback, surveys, and training results that provide insights into use-related risks. The evaluation of scientific literature complements this practical data and helps to place PMCF findings in an external context.

For targeted research questions, more specific designs are required. Product registries are particularly suitable for implants or widely used applications because they prospectively provide standardized outcome data over long periods. Prospective PMCF studies with a clear hypothesis, defined endpoints, and an a priori statistical design are the gold standard when it comes to methodically addressing a specific uncertainty in the CER. In addition, structured observational studies or retrospective analyses of medical records and registries are pragmatic options for quickly testing hypotheses or preparing the planning of prospective studies. Crucially, the choice of method depends on the research question: PMCF designs must be chosen to actually answer the questions formulated in the CER.

4. PMCF as a direct interface to clinical evaluation — how the integration works

PMCF is not an optional add-on; it is the lifeblood of your CER. In practical terms, this means that PMCF has a direct impact in two areas. First, PMCF specifically addresses the evidence gaps that remained during the marketing authorization process: endpoints, subgroups, or long-term questions not covered by preclinical studies are prospectively investigated and supported by robust rates and analyses. Second, PMCF provides real-world verification of your claims: the data show whether safety and performance are confirmed in everyday clinical practice or whether adjustments are necessary, be it to the benefit-risk matrix, claims in the IFU/label, or technical/organizational risk controls.

The integration process follows a transparent sequence: a PMCF trigger (CER gap or PMS signal) leads to the definition of a clear question and a PMCF plan with endpoint definitions. Data collection is carried out using the appropriate methodology (registries, prospective cohort, observational study). The results are formally summarized in the PMCF assessment report and incorporated into the PSUR/PMS report and the next CER version. Based on the data, the benefit-risk analysis is reviewed: claims are confirmed, refined, limited, or withdrawn; new risks are identified and recorded in the risk management file; necessary measures (IFU adjustment, CAPA, design changes, further PMCF) are implemented, and their effectiveness is subsequently monitored.

Without PMCF, the CER remains static and loses its connection to practice. With PMCF, however, you can demonstrate that your benefit-risk profile is up-to-date, your chain of evidence is traceable, and the clinical performance of your product has been proven in routine use. PMCF thus connects regulatory requirements with clinical reality: it fills gaps, validates claims, identifies new risks early on, and feeds the insights gained directly back into PMS, PSUR, and CER—in short, PMCF is the bridge between regulatory approval and everyday clinical practice.

5. Common mistakes (and how to avoid them)

PMCF is one of the most effective tools under the MDR, but also one of the most misunderstood. Even manufacturers who prepare well often stumble in its practical implementation and especially in its documentation. However, the typical pitfalls can be avoided by following clear principles.

A common mistake is treating PMCF as a one-off project: the study is conducted, the report filed, and the matter is considered closed. PMCF, however, is an ongoing process that extends throughout the entire product lifecycle. This problem can be avoided through regular reviews (at least annually for higher-risk products), the systematic integration of results into PMS, PSUR, and CER, and clear planning for follow-up analyses and potential expansions of the PMCF should new questions arise.

Equally critical is the lack of a link between PMCF and the Clinical Evaluation Report (CER). Results stored in isolation in a PMCF folder are of little use if they do not directly address the clinical claims or CER chapters. PMCF reports should already describe which CER update the data are incorporated into. This makes it clear which PMCF data supported or modified which conclusions in the CER.

Often, the methodological choice is justified too superficially: "We're conducting a survey" is not sufficient for notified bodies as a rational method for answering a specific open-ended question. Every PMCF method must justify why it is appropriate for the respective research question. This means explaining why registry data, a prospective cohort study, or an observational analysis addresses the remaining uncertainty, ideally with reference to the MDCG guidance on selecting appropriate methods.

Another mistake is collecting PMCF results but failing to translate them into action. If the data doesn't lead to entries in the Risk File, adjustments to the IFU, or CAPA measures, PMCF remains merely paperwork. Therefore, clearly document which PMCF findings triggered which specific decisions and demonstrate the subsequent effectiveness review. Auditors expect evidence that PMCF is not an end in itself, but actively guides risk management and clinical evaluation.

In short: PMCF is only as strong as its integration. If PMCF data is not systematically fed back into CER, PMS, and PSUR, it's not compliance, but rather formal fulfillment without clinical benefit. In practice, it's advisable to think of PMCF as your real-world clinical validation system: manage PMCF continuously, seamlessly link it to CER and Risk File, methodically justify every choice, and ensure high data quality and verifiable actions.

6. Conclusion

PMCF is the methodological core of post-market clinical evidence generation: well-planned and rigorously executed, it delivers the robust, real-world data that support claims, update benefit-risk analyses, and fill data gaps in the CER. PMCF is not an afterthought, but a strategic tool that enhances patient safety and ensures the regulatory robustness of your product, provided that PMCF activities are well-documented and fully integrated into CER and risk management.

7. How we can help you

We support you throughout the entire PMCF lifecycle: from deriving precise PMCF questions from CER and PMS, through study design, calculation and setup, to monitoring, biostatics and evaluation. We create PMCF plans and reports and help you with seamless integration with CER/PSUR/Risk File. 

Want to know more? Contact us for a free initial consultation!

You can get a free initial consultation here: free initial consultation

Post-Market Surveillance (PMS) as an interface to clinical evaluation

In this blog post, you'll learn which mandatory components an effective post-market surveillance (PMS) system must contain under the MDR, how to develop a targeted PMS plan and correctly use PMS reports or PSURs, which data sources (reactive and proactive) you should systematically evaluate, and how to practically assess identified signals and convert them into evidence. You'll also learn how PMS results can be seamlessly integrated into risk management, clinical evaluation reports (CERs), and PMCF measures.

Abbreviations

Underlying regulations and norms

EU Regulation 2017/745 (MDR)

MDCG 2022-21

1 Introduction

Post-market surveillance (PMS) is no longer a downstream regulatory step. PMS is central to transforming real-world usage data into robust clinical evidence. In light of the MDR, PMS is mandatory, systematic, reactive, and proactive: It provides the practical experience that proves whether the assumptions and claims in your Clinical Evaluation Report (CER) remain valid or need to be adjusted. The interface between PMS and clinical evaluation is therefore not an optional feature, but the crucial control tool for benefit-risk analyses, IFU/label changes, PMCF measures, and regulatory decisions.

In daily practice, we often see PMS data collected in isolation, stored in vigilance databases, service logs, or customer feedback systems, and only fed back into the clinical assessment when problems arise. This reactive approach is risky: It slows down necessary corrections, weakens the traceability of claims, and increases the likelihood of audit findings.

The aim of this article is therefore to provide the common thread on how to set up PMS as a continuous, traceable feedback loop: from planning through collection and analysis to systematic integration into CER, risk management and PMCF.

2. Core requirements of the MDR

The MDR elevates post-market surveillance (PMS) to the status of a mandatory, systematic, and proactive core task. PMS is not an afterthought, but rather the continuous tool manufacturers use to demonstrate and manage the actual safety and performance of their products in the field.

Article 61 paragraph 11 of the MDR is a clear, practical mandate for manufacturers:

(11) The clinical evaluation and the accompanying documentation shall be updated throughout the life cycle of the device in the light of the clinical data resulting from the implementation of the manufacturer's post-market clinical follow-up plan in accordance with Part B of Annex XIV and the post-market surveillance plan in accordance with Article 84.

 For Class III and implantable devices, the post-market clinical follow-up assessment report and, where appropriate, the summary report on safety and clinical performance referred to in Article 32 be updated at least once a year on the basis of those data.

The central starting point is a documented PMS plan for each product. This plan must be risk-based and product-specific, taking into account the product class, intended purpose, the environment of use (e.g., hospital, outpatient care, home use), and market characteristics. The PMS plan specifies which data sources are systematically monitored (e.g., vigilance reports, complaints, service and maintenance data, social media monitoring, PMCF results), who bears which responsibilities, which analysis methods are applied, and which trigger criteria trigger actions (e.g., thresholds, repeated incidents, increased incidences).

Regarding reporting obligations, the MDR differentiates between device groups:

For Class I devices, a PMS report be maintained and updated as needed. In practice, it has proven useful to review this report regularly (e.g., at predefined intervals, approximately every 3–5 years) and to make ad hoc changes to relevant signals.

For Class IIa, IIb, and III, the central formatting tool is the Periodic Safety Update Report (PSUR) . The MDR sets out clearer guidelines for PSURs: Class IIa at least every two years, Class IIb and III annually.

A PSUR is more than just a list: it must include a summary benefit-risk assessment, vigilance and trend data, PMCF results, sales/utilisation figures, CAPA measures and their effectiveness, and a conclusion on newly emerged risks or changed benefit-risks.

The key point is that PMS cannot be operated in isolation. The results from PMS monitoring must be directly incorporated into risk management (ISO 14971): Residual risks must be updated, risk controls reviewed, and expanded if necessary. PMS results must also provide direct input for the Clinical Evaluation Report (CER). Data and results that raise uncertainties regarding the efficacy or safety of a claim must be used as triggers for PMCF measures and processed in the benefit-risk analysis.

In short: PMS is the continuous feedback loop that generates real evidence and thus keeps your technical documentation, claims and clinical evaluation up-to-date, robust and audit-ready.

3. Reactive vs. Proactive — both sides of the PMS coin

An effective PMS strategy combines reactive and proactive activities into a closed-loop monitoring system: Reactive measures show what has already gone wrong or changed, including vigilance alerts, customer complaints, service and maintenance reports, field safety corrective actions, as well as media observations or reports of incidents involving competing products.

In contrast, proactive activities aim to generate evidence before problems escalate: Market analyses, targeted simulations and in-house tests (e.g., stress or retrieval studies), device data analyses, and continuous monitoring of SOUP components provide insights into actual performance and potential failure modes in real-world application environments. Proactive measures allow for the systematic testing of hypotheses arising from reactive signals and the generation of robust real-world evidence, which then leads to benefit-risk reassessments and CER updates.

The strength of a PMS system lies in the interconnectedness of both sides: Reactive data acts as early warning signals, while proactive activities verify root causes and evaluate countermeasures. Only through this combined approach can trends be identified early, reliable conclusions drawn, and well-founded, documented decisions made (e.g., IFU adjustments, CAPA, design changes, or PMCF initiation).

4. PMS as a direct interface to the CER — how the integration works

Post-market surveillance provides the real data with which evidence for clinical safety claims is updated in the CER. What is crucial here is not the sporadic "finding," but the structured, statistically meaningful documentation in the PMS report/PSUR: only then can reliable incidence rates be derived, temporal trends identified, and informed decisions made for benefit-risk reassessment.

Claims regarding clinical safety must be quantitatively substantiated with measurable data (e.g., incidence rates, severity levels, time periods). In practice, this means: The PMS report/PSUR should contain structured tables and analyses. Trends are not only presented descriptively, but also, for example, with appropriate trend tests or comparative analyses. This structured documentation forms the basis for integration into the CER: the rates and analyses presented in the PMS report/PSUR are incorporated into the benefit-risk matrix, claims are reviewed (confirmed, qualified, or withdrawn), and, if necessary, PMCF studies are initiated to gather targeted evidence. Predefined analysis methods in the PMS plan are crucial (e.g., relative increase in incidence > X%, statistically significant deviation).

Update of the clinical evaluation and benefit-risk reassessment: Relevant PMS signals (e.g., increased complication rates, recurring operator errors, new serious events) trigger a formal reassessment of the risks.

Identification of new risk types: PMS not only reveals changes in the frequency of known risks, but can also reveal entirely new hazards—such as material failures in certain batches, interference with third-party devices, software vulnerabilities, or application-specific risks for specific user groups. Such observations require a plausibility and root cause analysis and, if necessary, the inclusion of the new risk in the risk analysis (ISO 14971).

In short: PMS evidence for clinical safety claims is created through structured data collection and standardized, transparent analysis in the PMS report/PSUR—especially the calculation and interpretation of [number of points]. Only in this way can claims be robust, benefit-risk reassessments be traceable, and CER updates be audit-proof.

5. The operational PMS cycle — put into practice

The operational PMS cycle is not a theoretical diagram, but the practical framework used to translate real data into effective regulatory and clinical measures. To operate PMS as a living, audit-proof process rather than a silo, a clearly structured cycle is recommended.

In the "Plan " step, you create a product- and risk-based PMS plan. This plan defines objectives, data sources, signal detection criteria, responsibilities, analysis methods, and reporting cycles (PMS report, PSUR).

The Collect step ensures clean raw data. Collect both reactive (vigilance alerts, customer complaints, service/maintenance reports, FSCA data) and proactive data (in-house tests, market analyses).

In the Analyze section, you transform data into insights: perform trend analysis, cluster detection, and signal scoring (e.g., frequency × severity × plausibility). Every potentially relevant signal is documented.

The report step formalizes the results: Create or update the PMS report or PSUR according to MDR requirements – the structure and content depth specified in the MDCG Guidance 2022-21 is recommended. Use templates that contain a clear executive summary with a concise benefit-risk conclusion and define whether the benefit-risk balance is unchanged, improved, or worsened. The core part of the report should systematically map out the scope and sources of data collection (including basic UDI-DI and scope/"leading device" for device groupings), the reporting period, sales and usage figures, and the observed events with the calculation of incidence rates and, where appropriate, confidence intervals or other statistical indicators. Furthermore, vigilance and trend analyses, a summary of the PMCF results, CAPA summaries, and, if applicable, information on comparable devices should be included in the PSUR.

Act & Update step involves concrete measures: Initiate CAPA processes, IFU/label revisions, firmware patches, or user training. At the same time, update the risk management documents (ISO 14971) and the CER, documented with version numbers. Regular reviews of the PMS plan (e.g., after a PSUR release or in the event of design changes) are also important.

In conclusion, the operational PMS cycle is a dynamic, iterative process. Defined roles, standardized templates, and consistent traceability transform raw reports into robust clinical evidence and ensure that CER, IFU, and risk management documents always reflect the current real-world findings.

6. Common mistakes (and how to avoid them)

A common misconception is that PMS is simply about handling complaints. A PMS that only handles complaints is reactive and doesn't generate reliable real-world evidence. This can be avoided by demonstrating proactive activities: in-house testing, targeted market analyses, and analyses of similar products. Define in your PMS plan which proactive data sources you regularly query and document these activities in a report.

Another common mistake is confusing the PMS report (Class I) and the PSUR (Class IIa–III), or using the wrong reporting interval. The assignment must be clear: PMS report for Class I with needs-based updates, PSUR for IIa–III with cycles established by the PMS plan (e.g., IIa ≥ every 2 years, IIb/III often annually).

Very often, PMS results are not integrated into the other regulatory documents. PMS findings must not remain in a data silo; they must be incorporated into risk management documents (ISO 14971), the CER, and the IFU/label.

Outdated documentation is another common problem. Therefore, establish clear update cycles and documented justifications: annual mandatory updates for Class III/implantable devices, risk-based reviews for other classes, and ad hoc revisions for defined triggers (e.g., statistically significant deviations, clusters, new serious events). Each revision must be versioned, documented with the trigger, and released to prevent old claims or IFU versions from remaining in the field.

Weak trend analyses lead to reportable trends (Article 88 MDR) being overlooked. Implement methodical procedures for trend and cluster detection: calculate incidence rates with confidence intervals and use simple signaling scores with documented thresholds. Furthermore, document the statistical methods used and the decision boundaries in the PMS plan.

In summary: avoid isolated solutions, unclear reporting rules, weak methodology, and a lack of traceability by implementing proactive PMS activities, clearly defining reporting types and cycles, systematically linking PMS results with CER/risk management/IFU, introducing regular and trigger-based update processes, and implementing robust trend detection procedures.

7. Conclusion

Post-market surveillance is not a tedious chore, but the central control tool for transforming real-world usage data into robust clinical evidence. Only a well-defined, risk-based PMS plan that combines reactive reporting systems with proactive measures provides the signals that keep your benefit-risk analysis, claims, and IFU texts up-to-date. Avoid typical errors, isolated solutions, and poor data quality through structured templates, mandatory fields, and regular reviews. When PMS is established as a continuous cycle (Plan → Collect → Analyze → Report → Act & Update) and anchored both technically and organizationally, it becomes the driving force for patient safety, product quality, and regulatory robustness.

8. How we can help you

We provide pragmatic support throughout the entire PMS cycle—Plan → Collect → Analyze → Report → Act & Update—and ensure that your post-market surveillance truly serves as a robust interface to clinical evaluation. Concise and practical: we develop the PMS plan, implement structured data collection, conduct trend analyses and PSUR drafts according to MDCG specifications, and support CAPA, PMCF, and CER/IFU updates through to efficacy testing.

If you wish, we can start with a comprehensive gap analysis of your current PMS landscape and provide concrete, prioritized actions—making PMS not just a compliance task, but your tool for robust, ongoing clinical evidence.

Want to know more? Contact us for a free initial consultation!

You can get a free initial consultation here: free initial consultation

Evidence-based communication: Labels, IFUs & brochures as an interface to clinical evaluation

This blog post will show you how to safely and consistently translate clinical evidence from clinical evaluation into labels, IFUs and brochures, what requirements the EU-MDR and harmonized standards place on instructions for use and labels, and how to select verifiable claims from the CER and prepare them in a user-friendly way, both linguistically and graphically.

Abbreviations

Underlying regulations and norms

EU Regulation 2017/745 (MDR), Annex 1, Chapter III

EN ISO 15223-1

En ISO 14971

IEC 60601-1

IEC 60601-1-6

IEC 62366-1

1 Introduction

Labels, instructions for use (IFUs), and product brochures are more than just information sheets. They are the operational link between your clinical evidence and the everyday lives of users. Every sentence in an IFU, every warning on a label, and every claim in a brochure conveys clinical promises, safety guidelines, and instructions for use. If these statements cannot be directly and completely derived from the clinical evaluation, risks arise for patient safety, users, and regulatory approval.

In light of the MDR, consistency between the Clinical Evaluation Report (CER) and user documentation is of paramount importance: Indications, contraindications, warnings, and claims must be substantiated, clearly formulated, and presented in a user-friendly manner. Furthermore, usability results, vigilance cases, and PMCF findings continuously influence the content of IFUs and brochures. Therefore, stringent traceability and a clear, consistent narrative are essential.

2. Regulatory context and standards requirements

First and foremost is EU Regulation 2017/745 (MDR), Annex I, Chapter III ("Requirements for product-supplied information"): Labels, instructions for use (IFUs), and accompanying leaflets must be designed and completed in such a way as to ensure the safe and appropriate use of the product. Specifically, this means that indications, contraindications, warnings, instructions for use, and information on side effects must be clear, complete, and—very importantly—supported by clinical evaluation. Statements in user documents must not go beyond what is supported by evidence in the CER; otherwise, queries and, in the worst case, deviations during the review by notified bodies are likely.

Risk management according to ISO 14971 is the binding basis for determining which risks must be considered in user documentation: Use-related hazards must be identified, assessed, and addressed with appropriate measures as part of risk management. Remaining residual risks must be documented and justified in a benefit-risk analysis. The results of this analysis directly influence warnings, contraindications, and risk communication in user documentation.

The usability engineering process is defined normatively in IEC 62366-1: it specifies how use-related hazards are systematically identified, reduced through formative testing, and validated in a summative evaluation. Key performance indicators from these usability tests (error rates, task success rates, throughput times) are directly usable endpoints for the Customer Experience Process (CEP) and thus for documentation in the Customer Experience Framework (CER).

For active medical devices, IEC 60601-1-6 specifies usability-relevant requirements (e.g. alarm and display design, operability) that must be considered when designing IFU instructions and warning texts.

EN ISO 15223-1 provides guidelines for correct labeling and use of symbols: uniform graphic symbols on the device, packaging and in accompanying documents increase comprehensibility across language barriers and reduce misunderstandings, a relevant contribution to minimizing typical risks associated with use.

Only with this continuous link between regulatory requirements, risk management, usability data and clinical evaluation can consistent, traceable and audit-proof user communication be ensured.

3. IFU/Label content: What needs to be included — and how precise?

The accompanying documentation for a medical device (label, IFU, quick guide, product brochure, website, etc.) is highly relevant from both a regulatory and clinical perspective: it translates the claims, warnings, and usage instructions documented in the CER into practical application. Therefore, everything contained in a user document must be verifiable, understandable, and manageable. Furthermore, consistency must be maintained throughout the entire documentation.

3.1 Mandatory content

The EU MDR sets clear requirements regarding the information manufacturers must include with their medical devices. This information serves to uniquely identify the product and manufacturer and is intended to ensure safe and proper use. Product and packaging markings must therefore include information such as the product and trade name, model/type designation, package contents and intended use (if not obvious), the name and address of the manufacturer (or the authorized representative in the EU), the lot or serial number, and the UDI carrier.

Also mandatory are information on shelf life or manufacturing, instructions for storage and handling, sterility markings and sterilization procedures (if relevant), as well as clear indications of single use or restrictions on reprocessing.

For implantable or material-based products, the material information relevant to patients (qualitative/quantitative) must be provided; for products containing pharmaceutical or tissue components, appropriate information must be given.

The Instructions for Use (IFU) must contain all the information that users need for safe application: the complete intended purpose with indications, contraindications, patient target groups and intended users, where applicable the clinically expected benefit, the performance characteristics (e.g. measurement accuracy), information on the suitability of accessories and required software/hardware requirements, as well as all relevant residual risks, side effects, warnings and precautions.

For reusable products, cleaning, disinfection, and sterilization instructions must be provided, including clear criteria for recognizing when a product is no longer reusable, as well as information on the permissible number of reprocessing cycles. If the product is intended for single use, its technical characteristics and the risks associated with reuse must be specified. For radiation-emitting products, the type, intensity, and distribution of the radiation, as well as protective measures, must be documented. For products with programmable electronics or software, minimum requirements for hardware, IT networks, and security measures must be specified.

Practical requirements govern form and language. The Information and Functional Description (IFU) must be written in such a way that it can be easily understood by the user, supplemented, if necessary, by explanatory drawings or diagrams. International symbols (e.g., according to EN ISO 15223-1) may be used, but do not replace necessary textual information; symbols and colors used must be explained unless harmonized standards exist. Electronic provision of IFUs is permitted, provided the procedures specified in the regulation are followed. When several units are delivered to one location, a single IFU may be included if further copies are provided free of charge upon request.

3.2 Requirements for precision and verifiability

The precision and verifiability of statements are crucial: Claims must be supported by quantifiable outcome parameters already included in the CER (for example, "≥ 95% of measurements are within ± 0.3 °C of a reference method"). Statements in accompanying documents may only mention the populations, settings, and comparator measures that are supported by the evidence documented in the CER. Timeframes must be absolute ("within 12 months" instead of "short term"), and contextual information such as sample size, study design, or comparator reference should be referenced in the appendix or in a table if relevant to understanding. Unsubstantiated marketing phrases have no place in IFUs; every performance or safety claim must have a clear reference to the underlying evidence (claim ID, CER chapter) so that auditors can immediately trace the origin of the statement. Warning notices and instructions for action should be formulated in an action-oriented manner and be so specific that users can carry out the recommended measures in practice without having to ask questions.

Linguistic and design aspects also influence safety: short, active sentences, simple terminology, modular structure (quick start for rapid tasks and full IFU for details), standards-compliant pictograms, and a clear sequence logic reduce errors. Usability results should be used in formative evaluation to identify and simplify problematic wording. Summative data provides the numerical thresholds that are adopted as claims in the CER and subsequently in the IFU.

Marketing materials and brochures must be strictly separated from regulated user information: Marketing may communicate benefits, but may not use claims that have not been substantiated in the CER using clinical data.

4. Common mistakes and pitfalls

The same errors repeatedly creep in when translating clinical evidence into labels, IFUs, and brochures. Many not only lead to inefficiency but can also result in audit deviations or, in the worst case, patient harm. The following are the most common pitfalls, each with a brief explanation and pragmatic countermeasures.

a. Claims without sufficient evidence

Problem: The wording in the IFU/brochure is not fully based on the data documented in the CER.
Consequence: Discrepancies during audits, recall risk, legal issues.
Countermeasure: Use only claims from the CER; every claim wording must have a clear reference to the CER chapter/claims from the CER.

b. Imprecise or ambiguous wording

Problem: Vague statements (“improved”, “better”) or lack of context (population, comparison).
Consequence: User interpretations lead to misuse; marketing and IFU contradict each other.
Countermeasure: Use numerical, context-specific formulations (“≥ 95% within ±0.3 °C in adults”), which have already been used in the CER as outcome parameters for clinical performance claims. Conduct usability quick checks (5–8 users) before finalization.

c. Lack of traceability / no cross-references

Problem: IFU statements are not fully traceable back to the CER.
Consequence: Auditors cannot trace the origin of the claim.
Countermeasure: Maintain a traceability matrix – link marketing claims to the claims and evidence in the CER.

d. Inconsistencies between documents

Problem: The claim in the brochure differs in wording or measurement from the IFU/CER.
Consequence: Confusion among users, compliance risk.
Countermeasure: Traceability matrix maintenance, cross-functional review.

e. Translation errors and cultural misunderstandings

Problem: Technically inaccurate or misleading translations; icons not localized.
Consequence: Misuse abroad; liability risks.
Countermeasure: Expert translators; pictogram check according to ISO 15223-1; link to the original claim ID.

f. Late integration of usability results

Problem: IFU text is written before formative or summative usability findings are available.
Consequence: Text requires extensive revision or may fail to address user requirements.
Countermeasure: Usability input as a milestone before text creation; iterative draft reviews.

g. Unclear responsibilities / missing reviews

Problem: Who approves marketing claims, who authorizes IFU changes?
Consequence: Delays, unverified content circulates.
Countermeasure: Role matrix with clear responsibilities for approval.

5. From clinical evidence to claim: Translation process

The path from raw evidence in the CER to a permissible, understandable, and usable statement in the IFU, label, or brochure follows a clear, reproducible process. The goal is that every user statement is directly based on verifiable clinical evidence and formulated in a way that is understandable for the respective target group. This approach can be divided into five consecutive steps:

a. Claim Review and Initial Candidate List
: All statements are extracted from the CER. Since claims regarding clinical safety, clinical performance, and clinical benefit must already be substantiated with measurable outcome parameters in the CER, numerical results (e.g., "40% reduction in infection rate," "Measurement accuracy ±0.3 °C") can also be extracted. Each candidate receives a unique ID and is linked to the corresponding evidence source (Claim ID in the CER/CER chapter).

b. Wording: Precision and user focus.
Formulate statements in a quantifiable, concise, and context-sensitive manner:

• Prefer numerical data (“≥ 95% of measurements are within ± 0.3 °C”) rather than vague superlatives.
• Add context (population, comparison scale, time frame): "in adults using home methods vs. arterial blood gas analysis".
• Avoid misleading formulations or generalizations that go beyond the evidence.

c. Target group testing & usability review:
Check linguistic comprehensibility and practicality:

• Can the statement be correctly interpreted by the intended target group (doctors, nursing staff, laypersons)?
• Does a particular formulation lead to incorrect application or unintended assumptions?
  Ideally, the wording should be tested in a short usability review (at least 5–8 representative users); any problematic formulations should be revised.

d. Localization & Formatting
: For each language/region: professionally reviewed translation, adaptation of symbols (ISO 15223-1), layout checks (space for information boxes, highlighting). Version and translation QA with link to the claim ID.

e. Traceability, Documentation & Release
Every released statement must be traceable and linked to the evidence from the CER. A traceability matrix is ​​the best way to achieve this.

Quick checklist:

• Is the statement fully supported by CER evidence? ✔
• Is the wording quantifiable and context-specific? ✔
• Has the wording been reviewed by users (usability)? ✔
• Is the statement linked to the CER evidence in the traceability matrix? ✔

This structured translation process ensures that statements on accompanying documents are not only convincing, but also reliable, regulatory compliant, and understandable for the user.

6. Conclusion

Labels, IFUs, and product brochures are not mere marketing materials, but rather key regulatory documents. They translate the evidence documented in the CER into practical application, thereby ensuring patient safety, user-friendliness, and MDR compliance. Precision, verifiability, consistency, and complete traceability back to the CER are crucial.

7. How we can help you

Creating consistent and audit-proof accompanying documentation is complex: product claims must be precisely substantiated, texts must be formulated in a user-friendly manner, and they must be cleanly linked to the CER, risk management, and usability data. This is precisely where we come in.

We will support you in this,

• To translate claims from the CER into clear, verifiable user statements,
• To create IFUs, labels and brochures in compliance with regulations – from mandatory content to linguistic precision,
• to set up traceability matrices and review workflows,
• To efficiently integrate usability and vigilance data into your documents,
• and to provide training and practical checklists so that your team can sustainably apply processes independently.

Whether it's targeted claim validation or complete workflow establishment: We help you to design user documents that are not only formally correct, but also practical, understandable and internationally usable.

Want to know more? Contact us for a free initial consultation!

You can get a free initial consultation here: free initial consultation

Ease of use meets evidence: The interface between usability and clinical evaluation

In this blog post, you'll learn how to systematically identify potential use-related hazards and capture them in risk management, accurately translate these use risks into clinical endpoints, and then support them with robust evidence using formative and summary usability studies and simulations. You'll learn how to seamlessly integrate the obtained usability data into your benefit-risk analysis and clinical evaluation report.

Abbreviations

Underlying regulations and norms

EU Regulation 2017/745 (MDR)

En ISO 14971

IEC 62366-1

IEC 60601-1-6

1 Introduction

Clinical evaluation and usability (USAB) are still viewed as separate disciplines in many companies – different teams, different documents, different timelines.

However, the reality under the Medical Device Regulation (MDR, EU 2017/745) is different:
Clinical safety or clinical performance cannot be credibly demonstrated if the device is not fit for use in the intended application.

The MDR requires manufacturers to demonstrate that a medical device:

• is safe
• provides the intended service
• can be used safely and effectively in the hands of the intended user, in the intended application context

This makes it clear: Data from usability engineering are not a “nice-to-have,” but a central component of clinical evaluation and flow directly into the benefit-risk assessment.

2. Regulatory framework

The regulatory framework for linking usability engineering and clinical evaluation is based primarily on the MDR and the international standards ISO 14971, IEC 62366-1, and IEC 60601-1-6. According to Annex I of the MDR, medical devices must be designed to reduce usage-related risks to an acceptable minimum.

ISO 14971 standard integrates use-related hazards into risk management: Every potential user error is recorded as a hazard, assessed, and subjected to risk control. Remaining residual risks must be documented and justified in the benefit-risk analysis in the Clinical Evaluation Report (CER).

IEC 62366-1 standard defines the usability engineering process for all medical devices: starting with the creation of a use specification, continuing with the formal analysis of all use-related hazards and culminating in the summative evaluation. The data obtained (e.g., error rates, processing times) provide precise endpoints that are defined in the Clinical Evaluation Plan (CEP) and later evaluated in the CER.

IEC 60601-1-6 supplements these specifications for electrical medical devices with specific requirements for user interfaces, alarm and display design: For example, the readability of displays and the comprehensibility of alarm messages must be validated and documented.

3. What does usability mean?

In the context of medical devices, the term usability describes much more than "user-friendly design."
According to IEC 62366-1, usability is "the property of the user interface that supports use and thus achieves effectiveness, efficiency, and user satisfaction in the specified usage environment."

This definition makes it clear that usability is not just about aesthetic aspects or intuitive operation, but about the safe , effective and error-free use of a medical device - by the intended users, in the intended application scenarios and environments.

A usable product reduces the likelihood of use errors and thus directly contributes to patient safety and the fulfillment of regulatory requirements.

Conversely, poor usability and unclear user guidance can lead to risks that cannot be adequately compensated for by either product design or training.

3.1 Usability in the MDR

The MDR explicitly recognizes the importance of usability and enshrines it in several Essential Safety and Performance Requirements (GSPR):

• GSPR 5 – “Risks due to user errors shall be avoided or minimized through design and construction.”
  → This means: Manufacturers must actively identify which user errors could occur and eliminate or reduce these risks through design decisions during the development phase.
• GSPR 14.2(a) – “Risks of injury shall be minimized in conjunction with the physical characteristics of the product – including volume/pressure ratio, dimensions and, where applicable, ergonomic features.”
  → Ergonomics is not an optional comfort factor here, but a safety-relevant criterion that flows directly into the product design.
• GSPR 14.6 – "Measuring, control, or display devices shall be designed ergonomically, taking into account their intended purpose, the intended users, and the environmental conditions."
  → This applies, for example, to the readability of displays, logical menu navigation, the design of control buttons, or acoustic signals – everything must be adapted to the user and their environment.
• GSPR 22 – “Particular consideration of the abilities and limitations of lay users.”
  → Devices for home use or for patients themselves must be designed so that even persons without medical training can use them safely and correctly.

3.2 Why is this important?

A product that meets all regulatory requirements but is complicated or unclear to use in practice fails to meet its clinical performance requirements.
Usability is therefore not merely a design consideration, but an integral component of the safety and performance assessment and directly impacts the benefit-risk analysis in clinical evaluation.

In practice this means:

• Usability should be considered early in the development process (not at the end)
• Results from usability tests should be incorporated into risk management, IFU, labeling and clinical evaluation
• If changes are made to the user interface, risks must be reassessed and usability must be revalidated if necessary

4. The usability engineering process – more than just testing

Before linking usability and clinical evaluation can be successful, key terms and the underlying process must be clearly defined.

Use Specification:
The use specification comprehensively describes how and by whom a medical device is used. It defines user groups (e.g., nurses, physicians, lay users), application environments (hospital ward, home care, emergency use), and usage scenarios (routine injection, emergency response, long-term monitoring). A precise use specification serves as the basis for all subsequent steps, as it defines the context in which risks can occur.

Use-Related Hazards
A use-related hazard is a potential hazard that can arise from the use of the product, not from technical malfunctions, but from misuse, operating errors, or misunderstandings. Examples include confusing controls, inadequate cleaning, or unclear menu navigation. Each use-related hazard is identified in a formalized hazard analysis and documented in risk management.

Formative Evaluation:
In formative evaluation, prototypes or early product versions are iteratively tested with representative users. The goal is not to definitively demonstrate security, but rather to identify and resolve usability vulnerabilities early on. Common methods include task analyses, eye-tracking, think-aloud protocols, and structured observations. The insights gained are directly incorporated into design optimizations, ensuring that all the most serious use-related hazards are mitigated in advance in the final product.

Summative Evaluation:
The summative evaluation is the final, standards-compliant usability test. With the final product version, you conduct structured tests with typical users under realistic conditions and defined boundary parameters. The resulting key metrics, such as error rates, processing times, and success rates for safety-relevant tasks, are quantitatively evaluated.

Process overview

1. Create use specifications
   to define user profiles, application environments and usage scenarios.
2. Use-Related Hazard Analysis
   Identification and documentation of potential misuses in the risk register (integration into ISO 14971 process).
3. Iterative formative evaluation
   Early testing of prototypes, task analyses and usage observation for design optimization.
4. Implementation of mitigation measures
   : design adjustments, revised IFUs, training materials to minimize identified hazards.
5. Conduct summative evaluation,
   final tests with the final product, quantitative recording of the results.
6. Integration into the CEP/CER
   Transfer of the results into the Clinical Evaluation Plan and Clinical Evaluation Report, linking with benefit-risk analysis and risk management.

This structured process ensures that usability and clinical evaluation do not occur separately, but work in close coordination to ensure a safe, intuitive, and evidence-based medical device.

5. Interface: Usability → Clinical Evaluation

Transferring usability results into clinical evaluation ensures that risks typical of use are not only technically addressed but also validated. The process is divided into four consecutive steps:

5.1 Identification and prioritization of use-related hazards

In the first step, all potential misuses and operating errors are systematically recorded:

• from the use specification (e.g. switching on the device, making settings, reading parameters).
• In task analyses and workshops with representatives of the user groups (nursing staff, doctors, and possibly laypeople), you identify use-related hazards such as incorrect button selection, confusion of modes, or unclear displays.
• Using the risk table according to ISO 14971, you evaluate each hazard in terms of severity, probability of occurrence, and detectability. The prioritized risks form the basis for the clinical question.

5.2 Translation into endpoints

For each prioritized use-related risk, define one or more measurable endpoints :

• Error rate for safety-relevant tasks (e.g., percentage of users who fail to reset an alarm correctly)
• Average processing time until a critical process is successfully completed (e.g., start injection)
• Number of unnoticed alarms within a defined observation period.
  These endpoints must be clearly operationalized (measurement method, number of subjects, test conditions) and contain quantifiable acceptance criteria (e.g. error rate ≤ 2%).

5.3 Integration into benefit-risk analysis and CER

In the clinical evaluation, you link the usability endpoint results with the use-related risks documented in risk management, e.g., as:

• Tabular benefit-risk matrix: Each use-related hazard is compared to the measured endpoint, including quantitative results and assessment of the residual risk.
• Narrative evaluation: Explanation of how reducing the error rate or shortening processing times improves the clinical benefit-risk profile (e.g., faster therapy, lower patient burden).
• Claim derivation: Formulate precise claims based on the endpoint data (e.g., “Alarm reset successful in 98% of cases within 5 seconds”).

6. Example: Usability interface

To illustrate the procedure, let's look at a digital infrared ear thermometer:

1. ID

• Use-Related Hazard: False-negative temperature measurement due to improper probe alignment

2. Translation in endpoint

• Endpoint: Percentage of measurements whose deviation from the reference thermometer is ≤ ± 0.3 °C
• Acceptance criterion: ≥ 95% of measurements must meet the criterion

3. Evidence strategy

• Summative usability study:
  – n = 100 subjects (mixed user groups to cover the entire patient population)
  – Measurement in real home environments
  – Documentation of deviations and the number of incorrectly placed probes
• Supplementary simulation:
  – Laboratory bench test to determine the dependence of measurement accuracy on insertion direction (± 5° steps)

4. Integration into benefit risk analysis

5. Narrative

"In the summative study, 96% of users achieved the required measurement accuracy, keeping the residual risk of undetected fever cases to a minimum. The supplementary bench tests confirm that even small deviations in probe alignment only marginally affect accuracy."

6. Claim derivation
   “The digital infrared ear thermometer offers ≥ 95% measurement accuracy (± 0.3 °C) in real-world application environments.”

 This example illustrates how a use-related hazard is transformed into a precise clinical endpoint, which is validated through usability studies, documented in the CER, and finally converted into a quantifiable claim.

7. Conclusion

The consistent integration of usability into clinical evaluation not only increases user-friendliness, but is also essential for patient safety and regulatory compliance. By systematically identifying and prioritizing use-related hazards, deriving precise clinical endpoints, and planning and conducting formative and summative usability studies, you create robust evidence. The structured linking of this data with risk management and the benefit-risk analysis in the CER ensures seamless traceability and audit-proof documentation. This lays the foundation for medical devices that are both intuitive to use and clinically safe, meeting the requirements of users, auditors, and authorities.

8. How we can help you

We support you from the initial use specification to the final benefit-risk analysis, ensuring that your usability results flow seamlessly into the clinical evaluation. In joint workshops, we first develop your user profile, typical use cases, and identify all potential use-related hazards. We then plan and conduct both formative prototype tests and summative usability studies with representative user groups to generate reliable endpoint data.

We integrate this data directly into your CEP and CER. Together, we define precise endpoints, document the study results statistically, and link them to the corresponding risks in risk management.

In addition, based on your usability metrics, we formulate measurable, regulatory-compliant claims for your benefit-risk analysis and advise you on compliance with ISO 14971, IEC 62366-1, and IEC 60601-1-6 standards. This ensures that your medical devices are not only safe and intuitive to use, but also undergo clinically convincing evaluations and are approved quickly.

Want to know more? Contact us for a free initial consultation!

You can get a free initial consultation here: free initial consultation