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These include: • Application Audit Framework – with the recent publication of selection criteria and case management guidance • Electronic IFU (Instructions for Use) – regulatory amendments to allow eIFU • Boundary products – regulatory instruments to clarify regulatory categories • IVD classification and definitions – consultation submissions are being reviewed • ARTG variations – a working group is now underway to review processes • Essential Principles – Recommendations will be made to the Government following review of submissions received during the public consultation • Conformity Assessment Procedures Upcoming public consultation on international alignment • Adverse event reporting exemption rules • Medical Devices Vigilance Program • Excluded Software Review • Clarification of CDSS (Clinical Decision Support Software) regulation
