The EU’s pro­pos­al for a new Arti­fi­cial Intel­li­gence (AI) act could upset the reg­u­la­tion and the sup­ply of med­ical devices. The cur­rent pro­pos­al comes in addi­tion to med­ical device leg­is­la­tion. The addi­tion­al leg­is­la­tion indi­cates that man­u­fac­tur­ers must make sure that their noti­fied body intends to be des­ig­nat­ed and noti­fied under the AI act, includ­ing the new tech­nol­o­gy codes which may emerge under that leg­is­la­tion. If not, they may have to look for a new or addi­tion­al noti­fied body. 

Noti­fied bod­ies have inad­e­quate capac­i­ty under the EU reg­u­la­tions 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR). The AI act wors­ens the sit­u­a­tion even more and there could be treach­er­ous con­se­quences for the effec­tive­ness of the health­care sys­tem. The dead­line for com­pli­ance with the IVDR Class D IVD med­ical devices eli­gi­ble to ben­e­fit from the grace peri­od is 26 May 2025, Class C is 26 May 2026, and Class B and Class A devices placed on the mar­ket in a ster­ile con­di­tion is 26 May 2027. 

Since the AI reg­u­la­tion could be adopt­ed before the above dead­lines, man­u­fac­tur­ers who want to con­tin­ue plac­ing AI-enabled devices on the mar­ket have to per­form a con­for­mi­ty assess­ment under the AI act on them, irre­spec­tive of whether the AI act’s date of appli­ca­tion is before or after the end of the IVDR grace period. 

This could bring addi­tion­al dis­tur­bances to an already trou­bled med­ical device industry.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website