Category - elabeling

medicaldeviceslegal

Mobile medical apps update from the HIMSS

On Thursday 8 May I presented about EU regulation of mobile medical apps at the HIMSS Mobile Medical Apps roadshow in Berlin. The European Commisison’s Green Paper on mHealth has been hotly anticipated for quite a long time (at least by me!), so expectations were high. So high actually that I have not heard exultantly positive […]

medicaldeviceslegal

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 […]