Medical software

The DITTA Medical Software (MSW) Working Group (WG) contributes to the development of globally harmonised regulatory approach for software of medical devices and related IT networks and monitors development in various jurisdictions. The objective is to develop guidance which supports innovation and timely access to safe and effective Software as a Medical Device (SaMD) on a global scale. The DITTA MSW WG  identifies commonalities, establishes a common vocabulary and develops approaches for appropriate regulatory control which promotes the prospective convergence of advanced and innovative medical technologies.


  • Develop DITTA position and strategy with respect to IMDRF Work Item on Software as a Medical Device (SaMD)
  • For medical software, help provide clarity as to what software is subject to medical device regulations and if so, what requirements apply
  • Develop proposals that support a pragmatic implementation of relevant regulations for medical device with respect to software in general and in particular for standalone software
  • Contribute to the development on harmonised Guidelines on software as a medical device
  • Monitor regional trends (USA, Canada, Japan, China, etc.)
  • Include health IT-network security (cf. IEC 80001 series)