The Arti­fi­cial Intel­li­gence (AI) Act could lead to con­cerns about delays and prod­uct removals due to high demands, sim­i­lar to the warn­ings issued for lega­cy med­ical devices before the exten­sions were agreed. 

The cost of med­ical inno­va­tion in the EU, which already includes the imple­men­ta­tion of Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR), is expect­ed to increase even fur­ther due to the com­plex and intri­cate reg­u­la­to­ry envi­ron­ment that is being cre­at­ed by the imple­men­ta­tion of the AI Act.

This is a con­cern high­light­ed in a COCIR posi­tion paper on the Act, which was already pub­lished ear­li­er this year. COCIR is the Euro­pean trade asso­ci­a­tion rep­re­sent­ing the med­ical imag­ing, radio­ther­a­py, health ICT, and elec­tromed­ical indus­tries. The Euro­pean Coun­cil has signed off the Act late May, so its entry into force is expect­ed shortly.

The paper warns that new mea­sures from the AI Act may lead to extend­ed cer­ti­fi­ca­tion pro­ce­dures, increased devel­op­ment costs, pri­ori­ti­sa­tion of oth­er mar­kets, and diver­sion of resources from R&D in med­ical tech­nol­o­gy in the EU.

To ensure safe­ty, per­for­mance, and effec­tive­ness of AI-enabled med­ical devices, COCIR appeals for bet­ter align­ment mech­a­nisms between the AI Board and the Euro­pean Commission’s Med­ical Device Coor­di­na­tion Group (MDCG). The AI Board is being estab­lished to enable a seam­less, effi­cient, and uni­fied imple­men­ta­tion of the AI Act. It will pro­vide rec­om­men­da­tions and opin­ions to the Com­mis­sion con­cern­ing high-risk AI sys­tems and oth­er rel­e­vant aspects to ensure effec­tive and con­sis­tent enforce­ment of the new reg­u­la­tions. Addi­tion­al­ly, it will assist in stan­dard­i­s­a­tion efforts in this field.

Source: Medtech Insight (an Infor­ma product)

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