According to MDR (EU) Regulation 2017/745, IVDR (EU) 2017/746 and ISO 20417, printed matter comprises all information provided by the manufacturer that accompanies a medical device or its accessory, necessary to ensure its identification and its safe and effective use throughout its life cycle. This information must be easily accessible, whether it is on the device itself, on its packaging, or conveyed via digital tools, such as websites or QR codes, as specified in Annex I, point 23.1 of MDR.

The printouts include:

• Label: written, printed or graphic information on the device or its packaging (Art. 2(13) MDR/IVDR).
• Instructions for Use (IFU): information explaining the intended use, correct use and precautions to the user (Art. 2(14) MDR/IVDR). They are also known as ‘user manuals’ for electromedical equipment.
• Safety information: data, warnings and precautions for the user or person in charge of the organisation, i.e. risk control measures on labels and IFUs (ISO 20417).

Printouts may be provided in hard copy or, in some cases, electronically (e.g., via QR code, website, or USB stick), and must always ensure clarity and ease of access for the intended user.

Printouts as a user interface: usability and MDR compliance

Printouts are not only a documentation requirement, but are the main vehicle for regulated communication between manufacturer and user. Moreover, they are part of the broader concept of ‘Labelling’ of Medical Devices in the European Union. According to Article 2(49) of the MDR (EU) 2017/745, labelling includes all labels, instructions for use and any other information, indication, image or symbol accompanying a medical device or one of its accessories, including promotional and advertising materials, to correctly ensure the identification, use and safety of the product.

From this point of view, the design of printed matter must meet usability criteria, i.e., the information must be comprehensible to the intended user and not introduce any risks (Annex I, item 23.1 of MDR). Any message, whether text or image, must be accurate, verifiable and unambiguous, in line with MDR Article 7, which prohibits any misleading information on the use, safety or performance of the device.

Therefore, printed matter must be thought of as real user interfaces, designed to meet strict usability criteria. Technical reference standards, such as IEC 62366-1:2015 and IEC/TR 62366-2:2016, are an excellent guide for manufacturers in the application of usability engineering principles.

To be compliant, the printouts must be:

• Accurate and supported by evidence.
• Readable, indelible and understandable for the target audience.
• Consistent with technical documentation.
• Managed through structured documentary procedures.

Labels: compliance requirements, usability and document management

The information on the label must be indelible, legible and understandable for the intended user. To be compliant, the label must state:

• Harmonised standards applied, such as ISO 15223-1 (for the use of harmonised and standardised symbols) and ISO 20417 (general information requirements).
• UDI carrier: physical representation of the UDI (Unique Device Identification) for traceability and unique identification, including UDI-DI and UDI-PI.
• Language: it must be the one officially required by the country of marketing (Art. 10(11) MDR).

From a management point of view, the label is a controlled document in its own right and must be managed within the company’s quality system with:

• Traced Versioning and historical revisions.
• Documented approvals for each update.
• Correspondence with Technical Documentation.

Poor management can generate discrepancies and risks of non-compliance.

IFU and User Manuals: paper, eIFU and accessibility

The Instructions for Use (IFU) must be:

• Complete and easily understood by the intended user.
• Consistent with the intended use declared in the Technical File.
• Supported by illustrations, diagrams or graphs, if useful to enhance understanding.
• Drafted in the official language of the country of destination of the device, with validated translations.

IFUs must include at least:

• Manufacturer’s name or trademark.
• Specific intended use.
• Description of services provided.
• Installation, operation, cleaning and maintenance instructions.
• Warnings, precautions, contraindications and management of adverse events.
• Description of materials or components in contact with the patient.
• Instructions for proper disposal.

With the Implementing Regulation (EU) 2025/1234 of 16 July 2025, the possibility of providing IFUs in electronic format (eIFU) was extended to all devices for professional use. For devices intended for the general public (lay users), however, the obligation to supply them in paper format remains.

If IFUs are made available in electronic format, their publication on the manufacturer’s website is mandatory. The website becomes the designated access point for users to consult up-to-date instructions; the web address must be indicated on the labels of the device or in the printed instructions accompanying the product.

Best Practice in Drafting and Validation

Printouts management and validation are key steps to ensure that all device information is correct, up-to-date and compliant. In the company, printouts must be managed according to the document management procedure. Here are the key elements:

Document Management

• Structured approval flows with the involvement of the regulatory office.
• Change tracking and version control.
• Unique identification codes for each label version and IFU.
• Archiving of revision history and update date.

Validation

• Cross-review of regulation, quality and design.
• Involvement of usability experts to test clarity and readability.
• Documentation of audits with full traceability.
• Use of digital document management systems and approval workflows.

Mistakes to avoid

• Inconsistencies between IFU and Technical File.
• Unvalidated or incomplete translations.
• Promotional claims not supported by evidence.
• Manual management of versioning without control.

To prevent the most common errors, it is essential to: define roles and responsibilities, plan regular reviews, involve end-users for feedback, and use standardised checklists.

Promotional material: boundaries and regulations

While falling under the general concept of labelling, promotional material is distinguished from mandatory printed matter (labels and instructions for use) by its advertising and marketing purpose. Any claims, advertising messages, on these materials must be supported by documented scientific evidence and, above all, must be consistent with the intended use declared in the technical dossier. The main reference is the aforementioned Article 7 of MDR, which prohibits any text or image that could mislead as to the use, safety or performance of the device.

Promotional material can take many forms, including pamphlets, brochures, websites, social media content, congress and trade fair materials, stand fittings, totems and gadgets.

An essential distinction for determining the requirements applicable to health advertising concerns the recipient of the communication:

• Audience of non-professional (lay) users.
• Healthcare professional.

These two categories are subject to different regulations.

In Italy, Legislative Decree 137/2022 prohibits public advertising for:

• Tailor-made devices (Art. 2(3) of the MDR).
• Devices whose use requires the mandatory assistance of a health professional.
• Devices whose sale to the public is subject to medical prescription.

For devices not subject to these bans, advertising to the public is still subject to prior authorisation by the Ministry of Health.

The Circular of December 18, 2024, provides operational guidance on labelling, instructions for use and health advertising, representing an essential reference for manufacturers and economic operators involved in the communication of Medical Devices.

Frequently asked questions (FAQ)

Here are some answers to the most common questions about medical device printouts:

1. From a readability point of view, are there specific fonts to be used in printed matter? No, but ISO 20417 indicates ways to conduct readability tests.
2. Can the QR code be considered a printout? For example, to translate a text into many languages? Yes, because it impacts the use of the device and thus the safety of the product.
3. If standardised symbols of ISO 15223 are used, do they also have to be explained in the user manual?
   It depends on the type of user and the risk analysis. In some cases, it may not be necessary, but it depends on the approach of the Notified Body. Non-harmonised symbols may be used if they are adequately described in the UFIs; it could be a problem if the symbol only has English writing (e.g. MODE) if it is not clear or explained.
4. Can the manufacturer’s website also be a website dedicated to the product (and maintained by the manufacturer)?
   Yes, the site must be indicated in the IFU and/or be referred to on the manufacturer’s main site.
5. Does a device in sample format always have to be accompanied by IFU?
   If a provision is made, the product supplied free of charge must be accompanied by the same information as a product supplied against payment, i.e. all the information approved in the Technical Documentation. The making available of a medical device, according to Regulation (EU) 2017/745 (MDR), means the supply of a device for distribution, consumption or use on the Union market, whether in return for payment or free of charge.

Conclusion

Properly managing labels, IFUs, and information materials is not just a matter of compliance, but a strategic investment in patient safety and the manufacturer’s reputation. For medical device manufacturers, ensuring the clarity and accessibility of printed matter is a key responsibility. Any mismanaged information can turn into a risk of non-compliance or, worse, a usage incident. A robust document system, cross-validation and attention to usability are indispensable to ensure that the device is ‘MDR-ready‘ in every respect.

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