Under the initial ALKS regulation and its reference to the new cyber security requlation, manufacturers are permitted to use an alternative software identification system instead of the proposed RxSWIN format. This proposal seeks to clarify the use of such alternative identifications in the approval process.
35. The expert from France introduced GRVA-07-37, aimed to clarify the requirements for manufacturers using an alternative software numbering system differing from the Regulation No. x Software Identification Number (RxSWIN) one. GRVA welcomed the proposal.
36. GRVA agreed to resume discussion on GRVA-07-37 on the basis of a revised document, distributed with an official symbol at its February 2021 session.