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.

Proposal to clarify the explanation of the requirements of paragraph 7 and Annex 1 of the UN R156 (software updates and software updates management systems) and provide information on what may be used to evidence those requirements.

Proposal to ensure that the information provided regarding software updates is accessible for use in type approval, conformity of production, market surveillance, recalls and Periodic Technical Inspection (PTI).