The Euro­pean Commission’s new guid­ance (MDCG 2025-6/AIB 2025-1), which was already announced in a pre­vi­ous arti­cle, explains how the Med­ical Devices Reg­u­la­tion (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR) inter­act with the EU AI Act, espe­cial­ly for high-risk AI med­ical devices and IVDs (togeth­er called MDAI). 

Key Top­ics Covered

The document’s 36 FAQs are grouped into sev­en areas—Scope & Clas­si­fi­ca­tion, Man­age­ment Sys­tem Require­ments, Clin­i­cal & Per­for­mance Eval­u­a­tion, Con­for­mi­ty Assess­ment, Sub­stan­tial Mod­i­fi­ca­tions, Post-Mar­ket Mon­i­tor­ing, and Oth­er Questions—so stake­hold­ers can quick­ly find answers on data gov­er­nance, trans­paren­cy, human over­sight, cyber­se­cu­ri­ty, and more.

Key Aspects

The guid­ance con­firms that real-world testing(e.g., clin­i­cal inves­ti­ga­tions or per­for­mance stud­ies) of high-risk AI sys­tems can pro­ceed before mar­ket entry, pro­vid­ed it com­plies with EU or nation­al laws.

Man­u­fac­tur­ers must also ver­i­fy that their prod­uct qual­i­fies as both a med­ical device and a high-risk AI sys­tem, com­ply with MDR/IVDR and the AI Act, coor­di­nate assess­ments with noti­fied bod­ies, address AI-spe­cif­ic risks in tech­ni­cal files, ensure explain­abil­i­ty and human over­sight of AI out­puts, mon­i­tor for bias and per­for­mance issues, use high-qual­i­ty data, com­mu­ni­cate AI capa­bil­i­ties and lim­i­ta­tions clear­ly, reg­is­ter in rel­e­vant data­bas­es, and obtain CE marking.

The AI Act intro­duces addi­tion­al com­plex­i­ty to the MDR and IVDR by defin­ing ‘sub­stan­tial mod­i­fi­ca­tion’ and requir­ing the devel­op­ment of imple­men­ta­tion guide­lines, which will then need to be assessed for their impact on med­ical devices and IVDs. The AI Act man­dates that high-risk MDAIs under­go a new con­for­mi­ty assess­ment after a sub­stan­tial mod­i­fi­ca­tion, regard­less of whether they are dis­trib­uted or used by the same deploy­er. How­ev­er, if high-risk MDAIs that con­tin­ue to learn on the mar­ket adhere to a pre­de­ter­mined change con­trol plan checked dur­ing the ini­tial assess­ment, they are not con­sid­ered sub­stan­tial­ly mod­i­fied. 

It is imper­a­tive to clear­ly define and doc­u­ment pre-deter­mined changes dur­ing con­for­mi­ty assess­ment, ensur­ing they are adapt­able to the device’s evo­lu­tion, includ­ing ini­tial per­for­mance expec­ta­tions and mech­a­nisms for man­ag­ing post-mar­ket changes. 

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website