The date of appli­ca­tion for Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tics (IVDR) is approach­ing quick­ly. As of May 26, 2022, all man­u­fac­tur­ers of IVD med­ical devices will have to ful­ly com­ply to the new pro­vi­sions unless a valid CE cer­tifi­cate issued under IVD Direc­tive (IVDD) is avail­able. The lat­ter sce­nario will be applic­a­ble only for a very lim­it­ed num­ber of manufacturers.

The IVDR brings much stricter pro­vi­sions in many aspects, but one of the most crit­i­cal parts cer­tain­ly is the per­for­mance eval­u­a­tion with enhanced clin­i­cal data require­ments. This appears espe­cial­ly rel­e­vant because most IVD med­ical devices will see a more strin­gent clas­si­fi­ca­tion under the new reg­u­la­to­ry regime where addi­tion­al efforts may be need­ed to gen­er­ate the nec­es­sary data.

The Inter­na­tion­al Stan­dard­iza­tion Orga­ni­za­tion (ISO) has pub­lished stan­dard ISO 20916 “In vit­ro diag­nos­tic med­ical devices — Clin­i­cal per­for­mance stud­ies using spec­i­mens from human sub­jects — Good study prac­tice” in 2019. IVD med­ical device man­u­fac­tur­ers should care­ful­ly review the per­for­mance eval­u­a­tion process require­ments and also take ISO 20916 into con­sid­er­a­tion in this context.

Sources: ISO, IVDR

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing arti­cles on our website