Indus­try groups MedTech Europe and COCIR have sum­marised a num­ber of areas where the draft Arti­fi­cial Intel­li­gence (AI) Act could be mod­i­fied to enhance the poten­tial of AI in health care. They have co-signed a let­ter with 11 oth­er health organ­i­sa­tions appeal­ing to EU pol­i­cy­mak­ers to seri­ous­ly think about the impact the pro­pos­al will have on the EU ecosys­tem when decid­ing on the par­tic­u­lars of the final legislation. 

A vital pri­or­i­ty dur­ing the com­ing tri­logues is mak­ing sure that the AI Act is aligned with cur­rent reg­u­la­tions, includ­ing sec­toral leg­is­la­tion under the Med­ical Devices and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tions (MDR and IVDR). The Euro­pean Parliament’s nego­ti­at­ing posi­tion strives to get rid of reg­u­la­to­ry over­lap by con­sid­er­ing require­ments relat­ing to high-risk AI sys­tems as being met if they are already dealt with in sec­toral legislation.

The organ­i­sa­tions applaud the view­points of the Euro­pean Par­lia­ment, espe­cial­ly on con­for­mi­ty assess­ment and men­tion that fur­ther ref­er­ence to noti­fied bod­ies should be made, because this would amal­ga­mate the require­ments set out by sec­toral leg­is­la­tion even more. 

The let­ter goes on to say that if over­lap is not prop­er­ly tack­led dur­ing the tri­logue nego­ti­a­tion, the AI Act could estab­lish two-track sys­tems, where the AI Act applies for the AI com­po­nent of a device and the MDR/ IVDR to the rest of the prod­uct. This could lead to legal ambi­gu­i­ty and dif­fi­cul­ties in pro­vid­ing the eth­i­cal, safe and effec­tive devices that this Act meant to support. 

The AI Act must also align with oth­er hor­i­zon­tal EU exist­ing and pro­posed reg­u­la­tions, such as the Gen­er­al Data Pro­tec­tion Reg­u­la­tion, the Cyber Resilience Act, the Data Act, the Euro­pean Health Data Space Reg­u­la­tion and the revised Prod­uct Lia­bil­i­ty Directive. 

Addi­tion­al top­ics dis­cussed in the let­ter are the use of real-world data, AI lit­er­a­cy and a con­sis­tent imple­men­ta­tion of the AI Act with­in the Union.

Source: Medtech Insight (an Infor­ma product)

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