New MDCG Guid­ance Alert 

The Med­ical Device Coor­di­na­tion Group (MDCG) endorsed­MD­CG 20254, Guid­ance on the safe mak­ing avail­able of med­ical device soft­ware (MDSW) apps on online plat­forms, offer­ing prac­ti­cal guid­ance on safe­ly mak­ing med­ical device soft­ware apps avail­able through online platforms. 

Devel­oped under Reg­u­la­tions (EU) 2017/745 and (EU) 2017/746 (MDR and IVDR), it clar­i­fies roles of app providers, out­lines key infor­ma­tion and label­ing require­ments, and ensures apps mar­ket­ed in the EU meet med­ical device rules. This non­bind­ing guid­ance aims to har­mo­nize prac­tices, sup­port reg­u­la­to­ry com­pli­ance, and enhance patient safe­ty in the faste­volv­ing dig­i­tal health landscape.

The doc­u­ment can be down­loaded from our web­site.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Medtech com­pa­nies fac­ing risk of non-com­pli­ance as EU AI dead­lines approach
• EU noti­fied bod­ies on har­monised stan­dards regard­ing cybersecurity
• Guid­ance on Qual­i­fi­ca­tion and Clas­si­fi­ca­tion of Soft­ware under the MDR and IVDR Published