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

CEP	Clinical evaluation plan
CERIUM	Clinical Evaluation Report
IFU	Instructions for Use
MDR	Medical Device Regulation (EU Ordinance 2017/745)
Pmcf	Post-Market Clinical Follow-up
UDI	Unique Device Identification
USAB	Usability

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!

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