The Med­ical Device Coor­di­na­tion Group (MDCG) and the Arti­fi­cial Intel­li­gence Board (AIB) pub­lished MDCG 20256, Inter­play between the Med­ical Devices Reg­u­la­tion (MDR) & In vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR) and the Arti­fi­cial Intel­li­gence Act (AIA). 

This FAQ guid­ance clar­i­fies how the EU’s MDR and IVDR and the AIA inter­sect for AIbased med­ical devices. It out­lines scope, clas­si­fi­ca­tion, and com­ple­men­tary requirements—from risk man­age­ment to post­mar­ket sur­veil­lance—enabling man­u­fac­tur­ers, noti­fied bod­ies, and author­i­ties to stream­line com­pli­ance and ensure patient safe­ty. A time­ly tool to nav­i­gate the dual reg­u­la­to­ry frame­work for med­ical device AI across the EU.

The doc­u­ment can be down­loaded from our web­site.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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