Although medical device companies are not required to comply with ISO 13485:2016 until March of next year, the International Organization for Standardization (ISO) Technical Management Board is contemplating rewriting the quality systems standard. The group that oversees ISO 13485 revisions, the ISO Technical Committee 210 (TC210), has developed a survey to gauge how changing the standard now would impact device manufacturers and other major stakeholders. The survey, which can be found here, will close November 9.

When ISO 13485:2016 was being developed, TC210 received permission from the Technical Management Board not to write the standard in a “high-level” format. Since 2012, all standards published by ISO have followed this structure, which requires them to be harmonized in construct, text, terms, and definitions. However, for ISO 13485:2016, TC210 asserted that it would be difficult to apply this format to a device-related standard and the requirement was waived.

Technical Management Board

Now, the Technical Management Board is considering retracting the waiver and requiring that the policy be written in the standard, high-level format. If it is decided that the standard must be revised, the newest version would be issued in 2020 or 2021.

In response to the recent potential of a rewrite, TC210 has created a survey to assess how revising the standard could impact major stakeholders. The committee wants to “gather opinions from the users [of ISO 13485] to justify why no immediate revision is desired, especially in light of all the regulatory changes that are coming,” TC210 delegate Kim Trautman stated. The E.U.’s MDR and IVDR will be implemented in 2020 and 2022, respectively, and have already sent a massive ripple through the regulatory affairs operations for medical device manufacturers around the world.

Changing the standard now could also impact the U.S. FDA’s current plans to harmonize its Quality System Regulation with ISO 13485 and could call for changes to be made to parts of the Medical Device Single Audit Program (MDSAP). If the standard is rewritten, the International Medical Device Regulators Forum (IMDRF) may have to revise the program’s Audit Model and Audit Model Companion Document.

On Monday, November 12, TC210 will be meeting in Seoul, South Korea to review the results of the survey and use them to craft a reply to the ISO Technical Management Board. If you have opinions you would like to share on this issue, complete and submit the survey before tomorrow, November 9.

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