The EU AI Act is set to affect med­ical device com­pa­nies, with a main com­pli­ance dead­line of August 2, 2027, and some ear­li­er mile­stones com­ing as soon as Feb­ru­ary 2, 2025 where the lat­ter brings oblig­a­tions con­cern­ing pro­hi­bi­tion of cer­tain AI prac­tices and requir­ing AI lit­er­a­cy. This means among oth­ers that com­pa­nies will need to have their staff and users trained on the safe oper­a­tion of their AI-enabled prod­ucts by Feb­ru­ary 2, 2025 to com­ply with the require­ments on AI Literacy.

Med­ical tech­nol­o­gy firms that incor­po­rate AI into their devices tend to be clas­si­fied as high-risk under the Act, which means they must meet strin­gent require­ments sim­i­lar to those already in place under the med­ical devices and in vit­ro diag­nos­tic med­ical devices reg­u­la­tions (MDR and IVDR). While many aspects of the AI Act—such as qual­i­ty man­age­ment, post-mar­ket sur­veil­lance, and risk management—mirror exist­ing require­ments under the MDR and IVDR, there are new ele­ments to con­sid­er. One notable addi­tion is the require­ment to report seri­ous adverse inci­dents, which includes not only patient harm but also envi­ron­men­tal and prop­er­ty dam­age. Inte­grat­ing these new report­ing oblig­a­tions into exist­ing sys­tems will undoubt­ed­ly be challenging.

Noti­fied bod­ies like BSI and TÜV SÜD are already prepar­ing to assess med­ical device AI sys­tems under the new rules, but uncer­tain­ties remain about how many bod­ies will be des­ig­nat­ed and whether exist­ing soft­ware codes for med­ical devices can be reused or will need to be com­plete­ly redesigned. To nav­i­gate these com­plex­i­ties, med­ical device man­u­fac­tur­ers are advised to stick with the same noti­fied body for con­for­mi­ty assess­ments when­ev­er possible.

Addi­tion­al­ly, some products—such as men­tal health apps—might fall under more than one set of con­for­mi­ty require­ments, fur­ther com­pli­cat­ing the land­scape. While the Euro­pean Com­mis­sion is expect­ed to clar­i­fy these issues soon, the cur­rent ambi­gu­i­ty pos­es a sig­nif­i­cant risk, espe­cial­ly for small­er com­pa­nies. These are known for their inno­v­a­tive ideas and clin­i­cal exper­tise but often strug­gle with the exten­sive doc­u­men­ta­tion and qual­i­ty man­age­ment require­ments that larg­er firms can more eas­i­ly manage.

Over­all, while the align­ment of the AI Act with exist­ing reg­u­la­tions offers a com­pet­i­tive advan­tage by build­ing on famil­iar require­ments, the lack of clear def­i­n­i­tions and the intro­duc­tion of new oblig­a­tions mean that com­pa­nies must act swift­ly to ensure com­pli­ance before the dead­lines approach.

Source: Medtech Insight (an Infor­ma product)

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