Though both EN 1041 and ISO 20417 talk about the information to be supplied by the manufacturer along with the device, however the ISO 20417 standard offers more clarity on the requirements, being in compliance with the current regulations at the same time. The EN 1041 standard was drafted with keeping the MDD regulation in mind, however ISO 20417 is in compliance with the current MDR and IMDRF regulations.

While EN 1041:2008 reflected the requirements of the MDD (Annex I 10.4.1), ISO 20417:2021 aligns with MDR (Annex I 23.1), providing expanded detail on the legibility and durability of labels and markings, and clearer terminology on accompanying information. EN 1041, which previously provided requirements for information supplied by manufacturers with medical devices, has been withdrawn by CEN and replaced by ISO 20417:2021. ISO 20417 represents a significant advancement in labeling guidance, providing more detailed and comprehensive direction on how manufacturers should organize and present device information. The standard’s key contribution is its clear distinction between the “label” (information appearing on the device itself, its packaging, or on packaging of multiple devices) and “accompanying information” (such as instructions for use and other separate documentation). This structured approach helps manufacturers systematically organize the extensive information requirements mandated by regulations like the MDR.

ISO 20417

ISO 20417 also provides explicit guidance on the use of symbols, referencing ISO 15223-1 for standardized symbol libraries and defining when graphical representations may be used instead of text. This supports consistent, internationally recognized labeling and enhances user comprehension across languages and markets. In addition, the standard promotes internationalization support through recommendations on language designations and date formats, ensuring documentation remains clear and compliant across diverse regions while minimizing localization errors.

Further, ISO 20417 clarifies flexible placement options, explaining under what conditions information may appear on the device, on its individual packaging, or within accompanying documentation—particularly useful for small or specialized devices where direct marking is impractical.

Importantly, the standard also emphasizes integration with risk management principles, linking labeling content to ISO 14971 risk-control strategies. This ensures that safety-critical information identified as part of the risk-management process is properly communicated through labeling and accompanying documentation, supporting safe and effective device use.

ISO 20417’s terminology and structure align closely with the MDR’s approach, though the terms are not identical. The MDR differentiates between “label” (written, printed, or graphic information on the device or its packaging) and “labelling” (which encompasses the label, instructions for use, and all other information provided by the manufacturer). By following ISO 20417’s guidance, manufacturers can more effectively address the MDR’s requirements in Annex I, Chapter III—particularly in determining what information should appear on the label itself versus what belongs in the instructions for use.

While ISO 20417 is intended for harmonization under the MDR and is widely recognized by Notified Bodies, manufacturers must ensure their labeling directly fulfills all applicable MDR requirements and regulatory expectations.