Indus­try has been wor­ried for some time about con­ver­gent EU reg­u­la­tions con­cern­ing med­ical devices and cyber­se­cu­ri­ty. Trade asso­ci­a­tions like MedTech Europe believe that hor­i­zon­tal leg­is­la­tion, such as the Arti­fi­cial Intel­li­gence (AI) Act pro­pos­als, could over­lap with Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR), result­ing in reg­u­la­to­ry frag­men­ta­tion and uncer­tain­ty among med­ical device manufacturers. 

In addi­tion, oth­er leg­is­la­tion, such as the EU Direc­tive on Secu­ri­ty of Net­work and Infor­ma­tion Sys­tems (NIS Direc­tive) and its pro­posed revised form, NIS2 could oblige man­u­fac­tur­ers to dupli­cate cer­tain duties.

The sit­u­a­tion is high­ly dynam­ic and man­u­fac­tur­ers and asso­ci­at­ed enti­ties are well-advised to have a close eye on the cor­re­spond­ing developments.

Source: Medtech Insight (an Infor­ma product)

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