What is BS EN ISO 20417 - Medical devices - Information to be supplied by the manufacturer about?
BS EN ISO 20417:2026 specifies the requirements for the information that manufacturers must supply with medical devices and accessories. This includes information provided on the device itself, on packaging, through labelling and within accompanying documentation such as instructions for use.
The standard acts as a central reference point for generally applicable information requirements, enabling product specific standards to focus on the unique characteristics of individual devices.
Its primary aim is to ensure that medical devices can be used safely and effectively by providing clear, consistent and reliable information to users.
Who is BS EN ISO 20417 - Medical devices - Information to be supplied by the manufacturer for?
This standard is intended for all organizations involved in the medical device lifecycle, including:
- Medical device and accessory manufacturers.
- Regulatory affairs and compliance professionals.
- Quality management and risk management teams.
- Importers and distributors.
- Software, digital health and AI medical device developers.
- Notified bodies and regulatory authorities.
- Healthcare professionals and organizations involved in device use and procurement.
It is particularly valuable for organizations seeking to meet international regulatory expectations and market medical devices across multiple regions.
What does BS EN ISO 20417 - Medical devices - Information to be supplied by the manufacturer cover?
BS EN ISO 20417:2026 covers the generally applicable requirements for information supplied by the manufacturer, including:
- Identification and labelling of medical devices and accessories.
- Information appearing on packaging and device markings.
- Accompanying information, such as instructions for use (IFUs), symbols and technical descriptions.
- Requirements that support usability, legibility, durability and clarity of information.
- Alignment with risk management and usability engineering principles.
The standard does not prescribe how the information must be delivered (for example, paper versus electronic), allowing flexibility while maintaining consistency and safety.
Why should you use BS EN ISO 20417 - Medical devices - Information to be supplied by the manufacturer?
BS EN ISO 20417:2026 provides clear, internationally aligned requirements for information supplied with medical devices, supporting safe use, regulatory compliance and global market access. The benefits vary across different user groups:
- Medical Device Manufacturers: Supports global regulatory compliance, reduces risk related to labelling and information errors, and enables faster and more efficient access to international markets.
- Regulatory Affairs Professionals: Provides an aligned and consistent framework for documentation, simplifying multi market submissions and interactions with regulators and notified bodies.
- Quality & Compliance Teams: Strengthens quality management systems (including alignment with BS EN ISO 13485), supports risk management activities and improves traceability across the device lifecycle.
- Importers & Distributors: Helps ensure accurate labelling and complete accompanying documentation, supporting safe handling, distribution and legal compliance in different markets.
- Software and AI Medical Device Developers: Clarifies documentation and information requirements for digital and software based devices, supporting usability, transparency and cybersecurity considerations.
- Notified Bodies & Regulators: Offers a consistent and recognised benchmark for conformity assessment, regulatory review and auditing of information supplied by manufacturers.
What’s changed?
This 2026 edition is a technical revision that replaces the previous edition, BS EN ISO 20417:2021. Key changes include:
- Updates to normative references to reflect current standards.
- Removal of several former informative annexes (Annexes D, F, G and H).
- Introduction of the term “applicable policy” to improve clarity and consistency.
- Deletion of specific items within Clause 4 and Clause 6.1.2 to streamline requirements.
These changes refine the structure and clarity of the standard, making it easier to apply in practice while maintaining alignment with evolving regulatory expectations.