ISO 20417, which covers information provided by manufacturers for medical devices (MD) and in vitro diagnostic medical devices (IVDMD), is scheduled for revision in 2026.
This new edition introduces significant structural changes designed to improve consistency, clarity, and alignment with regulatory requirements, particularly those of the MDR and the IVDR.
What are the main differences between the 2021 and 2026 versions? What are the implications for manufacturers? An in-depth look.
Regulatory Context
ISO 20417 defines the general requirements for information provided by the manufacturer, including:
- the labeling of medical devices,
- the information on the packaging,
- accompanying documents (user manuals, instructions, etc.).
The 2026 version replaces the 2021 edition, with a clear objective:
- make the requirements clearer,
- improve their applicability,
- and ensure greater consistency with recent regulatory changes.
Key Changes in ISO 20417:2026
1. Reorientation of Normative References
One of the major changes involves reducing and clarifying the list of standards.
The 2021 version included an expanded set of standards (ISO 13485, ISO 16142, IEC 62366-1, etc.).
The 2026 version takes a more targeted approach, drawing in particular on:
- ISO 14971 (risk management),
- ISO 15223-1 (labeling symbols),
- ISO 7000, ISO 7010, and IEC 60417 (graphical symbols).
👉 This change reflects a desire to simplify the process and focus on requirements directly related to the information provided.
2. Removal of correspondence attachments
Several informative appendices included in the 2021 version have been removed, notably those establishing correspondences with:
- regulatory requirements,
- the essential principles,
- safety and performance requirements.
👉 In version 2026, these mappings are no longer built in directly.
Eventually, they should be included in Annexes ZA/ZB of the harmonized EN ISO standards, thereby establishing a link to the MDR and the IVDR.
3. Explicit Introduction of the Concept of “Applicable Law”
Version 2026 introduces a major change: the concept of “applicable law.”
This concept is now directly incorporated into the requirements and covers all regulatory obligations in the countries where the device is marketed.
In particular, it affects:
- the language of the information provided,
- the content and format of labels and package inserts,
- the guidelines for presenting the information.
👉 Unlike the 2021 version, in which these aspects were implied, the standard now clearly formalizes the link between normative requirements and regulatory requirements.
4. Reducing flexibility and clarifying requirements
Certain provisions that provided flexibility to manufacturers have been removed, including:
- the option to use more recent versions of standards under certain conditions,
- certain specific options related to the labeling of the authorized representative.
👉 This change is intended to:
- to minimize differing interpretations,
- strengthen harmonization,
- and ensure compliance with the requirements.
Conclusion
The 2026 version of ISO 20417 takes a more structured, more explicit approach that is better aligned with regulatory requirements.
The main changes are:
- a refocusing of normative references,
- the explicit incorporation of applicable legislation,
- the removal of correspondence appendices,
- and a reduction in flexibility in application.
Need some help?
Isocèle Conseil assists you in organizing and ensuring compliance of the “information provided by the manufacturer” in accordance with the requirements of ISO 20417, the MDR, and the IVDR.