The 2026 edition of the standard responds to the growing need for harmonization with the European MDR and IVDR regulations, as well as the ongoing digitalization of the medical sector. The standard moves away from a static labelling model toward the dynamic management of information throughout the entire device lifecycle. The new structure of the standard places a heavy emphasis on the manufacturer’s information strategy, which links the physical data on the device packaging with device information available in IT systems and the EUDAMED database.

While many core principles remain aligned with the 2021 version, the new edition introduces structural reorganization and departs from previous approaches to documentation. Instead of re-analyzing familiar definitions, manufacturers should focus on significant process innovations that are now mandatory and require implementation within Quality Management Systems (QMS).

The new edition of the standard places a particular emphasis on the manufacturer’s so-called information strategy. Information supplied with a medical device is no longer treated as an independent design element – it has become an integral part of usability engineering and risk analysis. What does this mean in practice?

New requirements in risk management

One of the most significant formal changes concerns the direct marking of devices. In the medical industry, it was common practice for small-sized products to automatically transfer identification data to the outer packaging. ISO 20417:2026 puts an end to this automatic assumption. If you choose to omit physical marking on the device itself, you now have an obligation to document and approve a detailed justification for this decision directly within your risk management documentation in accordance with ISO 14971.

This process-driven approach is also evident in the requirement that any modification, shortening, or omission of standard information in the IFU or technical description must unconditionally stem from a formal risk assessment. From an auditing perspective, this means that conformity assessment of labels will no longer be a purely visual review of the artwork; auditors will verify the explicit links between labelling elements, the IFU, and the risk register.

Usability engineering: instructions from a layperson's perspective

Another major milestone is the change in requirements for devices intended for non-professional users. The standard introduces a criterion stating that instructions for use dedicated to a layperson must be developed at a level corresponding to a lower secondary school education. Exceptions are permitted only where the device's usability specification — backed by usability studies — defines and justifies a different target user profile. For Regulatory Affairs departments, this is a clear signal: patient instructions must be reviewed for linguistic simplicity and the elimination of dense medical jargon.

From a documentation structure perspective, the approach to multi-part instructions is also new. If the accompanying information is split into several parts (e.g., a separate quick-start guide, user manual, and maintenance instructions), at least one of these documents must contain a complete index of all components within the instruction set and accompanying documentation.

Digitalization, e-IFU, and Cybersecurity challenges

In the realm of electronic documentation, the 2026 standard presents manufacturers with entirely new data security challenges. When making instructions available online, the manufacturer must now assess — as part of the risk management process — whether access to specific information (e.g., technical configurations or service procedures) should be restricted. Consequently, there is an obligation to design and implement systemic access control measures for parts of digital portals on which information for users is displayed.

At the same time, before abandoning paper format in favor of e-IFU, the standard explicitly commands the verification of local legal regulations. The choice of language for supplementary text accompanying safety signs has also been given a rigid hierarchy: national laws of the given jurisdiction take absolute priority, followed secondly by the language appropriate for the user. In the European Union, this directly refers to the language requirements imposed under Article 10(11) of the MDR (EU) 2017/745 Regulation (and correspondingly Article 10(9) of the IVDR (EU) 2017/746 Regulation), as further specified in the official European Commission document: Language requirements for manufacturers of medical devices.

Label optimization and new graphical symbols

Amidst the array of new obligations, standardizers have also introduced changes that ease space management on device packaging. The best example of this is the status of importer data. Up until now, the 2021 standard mandated its placement directly on the device label. The 2026 version introduces long-awaited flexibility: if there is insufficient space on the label, the importer's data can legally be moved to the accompanying documentation.

Additionally, ISO 20417:2026 authorizes the use of new pictograms to replace text with graphical forms:

• ISO 7000-2794: for unambiguously indicating the net quantity of items within a package.
• ISO 7000-1640: for the official marking of technical description documentation (service manuals).
• ISO 14617-2:2025 (symbols 3869 i 2066): new markings to precisely define environmental conditions strictly during transport and storage.

Globalization of the standard: Changes to the Annexes

The most noticeable structural change in the new edition is the complete removal of Annexes G and H, which in the 2021 version mapped the clauses of the standard to the European General Safety and Performance Requirements (GSPR under MDR/IVDR). This removal officially grants the standard a truly global character.

What do these changes mean for manufacturers?

Adapting your organization to the realities of ISO 20417:2026 should not be postponed. First and foremost, it is recommended that every new labelling project triggers an analysis of the new pictograms and a review of e-IFU security measures. In parallel, risk management report templates must be updated to include sections dedicated to justifying the omission of physical marking on small devices.

1. Ensure that all references to symbols are updated to the ISO 15223-1:2021 standard (including amendments).
2. Verify that any deviation from a full physical label on the device is justified in the risk management report.
3. If you provide patient instructions, verify their readability against the new language level requirement. 
4. Ensure that, for multi-part instructions, at least one document contains the complete index.

ISO 20417:2026 is a more "living" and systemic standard than its predecessor. Its implementation brings greater order to communication with users and supervisory authorities, which ultimately raises device safety in the long run.

Need help mapping your documentation to the new version of the standard? Contact our team of experts!