Like all ISO standards, ISO 13485 is subject to a periodic revision cycle. The current version dates from 2016 — a revision is therefore being prepared as part of ISO’s normal process. At this stage, the work is in its preparatory phases, and the publicly available information makes it possible to identify likely directions of change without prejudging the final content.
What the ISO revision cycle involves
The process for revising an ISO standard goes through several formal stages: publication of a call for comments (CD, Committee Draft), then a draft international standard (DIS, Draft International Standard), then a final draft (FDIS, Final Draft International Standard), before the revised standard is published. This process generally takes several years.
Once published, the revised version of ISO 13485 will give rise to a transition period during which both versions (old and new) are recognised. Certifications issued under the previous version will remain valid during this period.
Likely directions of change
Without prejudging the content of the revised version — which is not finalised to date — several directions of change are consistent with discussions within the standardisation community.
Better alignment with MDR and IVDR requirements. The 2016 version was published before the MDR. The revised version will most likely be more explicitly aligned with the requirements of the MDR and the IVDR, in particular on post-market surveillance, clinical evaluation, and vigilance obligations.
Integration of cybersecurity risks. Medical device cybersecurity was not a topic in the 2016 version. A future version could integrate specific requirements on this theme, in line with the MDCG 2019-16 guidelines and developments in the IEC standards.
Strengthening of software requirements within the QMS. Section 4.1.6 on the validation of QMS software could be expanded to better cover modern digital environments.
How to anticipate without overreacting
The common-sense rule is not to modify your QMS in anticipation of a standard that has not yet been published. On the other hand, building a robust QMS on the 2016 version — properly covering all its chapters, including those that will most likely be strengthened — is the best preparation for a future revision.