The Euro­pean Asso­ci­a­tion for Med­ical devices of Noti­fied Bod­ies (TEAM-NB) are ask­ing the Euro­pean Com­mis­sion to think again about a pro­posed reg­u­la­tion that could lead to rep­e­ti­tion in reg­u­la­to­ry require­ments for arti­fi­cial intel­li­gence (AI) prod­ucts. Under the Arti­fi­cial Intel­li­gence Act (AIA), AI prod­ucts, includ­ing med­ical devices and spe­cif­ic med­ical soft­ware, would encounter risk-based reg­u­la­to­ry require­ments so that they can be placed on the Euro­pean mar­ket. Med­ical devices and Soft­ware as a Med­ical Device (SaMD) which use AI would be deemed as high-risk.

How­ev­er, TEAM-NB says sec­tor-spe­cif­ic safe­ty require­ments are already dealt with under the Euro­pean Commission’s New Leg­isla­tive Frame­work (NLF), and more specif­i­cal­ly is cov­ered under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR). When it comes to AI reg­u­la­tion, it is vital to focus on the enforce­ment under the exist­ing NLF frame­work to pre­vent defrag­men­ta­tion, work dupli­ca­tion, save on costs, and avoid upsets to oper­a­tion efficiency. 

The asso­ci­a­tion advis­es the EU to cre­ate indus­try-spe­cif­ic guid­ance for putting AI reg­u­la­tions into prac­tise with the exist­ing NLF frame­work to deal with risk, state of the art, test­ing and assess­ment obligations. 

TEAM-NB says that the AIA pro­pos­al uses a broad def­i­n­i­tion of AI which could take in non-AI sys­tems and con­found reg­u­la­tors, man­u­fac­tur­ers and noti­fied bod­ies. To ful­fil the object of stan­dard­i­s­a­tion, har­monised def­i­n­i­tions of tech­nolo­gies, so that the rel­e­vant stake­hold­ers can cor­rect­ly com­mu­ni­cate, the def­i­n­i­tion found in the inter­na­tion­al stan­dard ISO/IEC 2382:2015, IT vocab­u­lary ought to be used. 

The asso­ci­a­tion are also trou­bled about the AIA proposal’s require­ments for vig­i­lance report­ing and con­for­mi­ty assess­ments. There are already sys­tems in oper­a­tion to deal with these mat­ters and bring­ing in new require­ments would dou­ble the work­load and add unnec­es­sary inconvenience.

Source: Medtech Insight (an Infor­ma product)

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