More on mHealth and e-labeling

Further to my recent post about e-labeling and my appeal to take more account of the specific mHealth market needs I had a discussion with another devices expert who suggested that the majority of medical apps will be in class I anyhow, in which  case these apps can be used safely without instructions, because the Medical Devices Directive provides for an exception in that case and no IFU is needed. Consequently, the app could contain e.g. an electronic application guide only. Background This argument r [...] « Read the rest of this article on medicaldeviceslegal »