Good news for medical device manufacturers: ISO 13485:2016 will remain unchanged for another five years. This means no major changes are to be expected to quality management systems that already comply.
This was particularly important because the US authority FDA has just updated its own quality management framework. In the new Quality Management System Regulation (QMSR), the FDA references many requirements from ISO 13485:2016. Had ISO 13485 been changed in the meantime, companies would probably have had to make major adjustments to remain compliant in both the USA and the EU.
The focus now turns to the handbook on ISO 13485, planned as ISO/TS 23485. Publication can currently be expected in April 2026 at the earliest.