The Med­ical Device Coor­di­na­tion Group (MDCG) has pub­lished a long await­ed guid­ance doc­u­ment in Octo­ber on the qual­i­fi­ca­tion and clas­si­fi­ca­tion of soft­ware under Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR). 

The doc­u­ment intends to pro­vide clar­i­ty pri­mar­i­ly for med­ical device soft­ware man­u­fac­tur­ers under which cri­te­ria a soft­ware falls with­in the scope of the MDR or IVDR and how clas­si­fi­ca­tion rules are to be under­stood and applied.

Experts crit­i­cized the guid­ance almost imme­di­ate­ly after pub­li­ca­tion for being not clear enough in impor­tant aspects.

Sources: MDCG guid­ance documents

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