Review of scope of ISO/TC 210
At the ISO/TC 210 plenary meeting last May, it was briefly discussed that the wording of the scope of ISO/TC 210 should be revisited to see if it is still up to date. After the plenary meeting, resolution 307 was accepted by the ISO/TC 210 membership (see N1283). This resolution mandates ISO/TC 210 to establish an ad hoc group with the task to "review the current scope of ISO/TC 210 and determine whether any editorial changes to improve clarity and alignment with the current work programme should be proposed."
It is not the intent to fundamentally alter the scope of ISO/TC 210. However, part of the discussion may target whether health products can also be considered within the scope of ISO/TC 210 even if they do not fall within the definition of a medical device, a legal definition that varies by jurisdiction.
It is expected that, if the ad hoc group believes that an update of the scope statement is necessary, proposals to that end will be published for comments prior to the next plenary meeting. A possible final proposal will be tabled for adoption at the next plenary meeting.