Back in 2021, the Euro­pean Com­mis­sion pro­posed a reg­u­la­tion on gen­er­al prod­uct safe­ty (GPSR). The aim is to imple­ment the reg­u­la­tion thus repeal­ing the cur­rent­ly valid directives. 

The GPSR pro­vides for aspects like cyber­se­cu­ri­ty and post-mar­ket sur­veil­lance. It is planned to entry into force until mid-2023 and to become oblig­a­tory by the end of 2024.

Man­u­fac­tur­ers of med­ical devices are not exclud­ed from the scope of the reg­u­la­tion. Crit­i­cal voic­es are con­cerned that over­laps with oth­er (planned) reg­u­la­tions, like for exam­ple cyber­se­cu­ri­ty or arti­fi­cial intel­li­gence, cause con­fu­sion and overregulation.

Source: John­er Institute

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website