ISO has completed the 2025 systematic review of ISO 13485:2016 and confirmed the current edition. In practice, that means there is no new version and no adoption of the Annex SL / High-Level Structure at this time.
Why this matters
- Manufacturers and suppliers can continue using existing ISO 13485:2016-based QMS without re-structuring to Annex SL.
- Alignment efforts with regulators (e.g., FDA QMSR’s incorporation of ISO 13485) remain unaffected.
- If ISO decides to revise ISO 13485 in future cycles, Annex SL could resurface; for now, the 2016 edition remains current.
What manufacturers should do now
- Continue operating under ISO 13485:2016 — no changes to your QMS structure or documentation are required.
- Monitor regulatory alignment — the FDA’s Quality Management System Regulation (QMSR) and MDR/IVDR expectations remain based on the 2016 version.
- Verify certificate validity — certification bodies will maintain current ISO 13485:2016 certificates; ensure your audit cycle remains on track.
- Stay informed — watch for official announcements from ISO/TC 210 and your national standards body regarding any future revision plans.
- Communicate with your supply chain — confirm suppliers and subcontractors are aware that no revision or Annex SL restructuring applies.
Sources: ISO catalogue (status “confirmed in 2025”); ISO/TC 210 background on possible HLS adoption if revised; national member communications on the 2025 review; industry updates from TC 210 participants.
Disclaimer
This article is intended for informational purposes only and reflects QNET’s interpretation of publicly available information from ISO and national standards bodies as of November 2025. ISO 13485 remains under the ownership and control of the International Organization for Standardization (ISO). Users should always consult the official ISO catalogue and their certification body for authoritative updates or requirements.