bsi arti­cle on clin­i­cal eval­u­a­tion require­ments under the MDR

Noti­fied body bsi has pub­lished an arti­cle in Feb­ru­ary in the Jour­nal of Med­ical Device Reg­u­la­tion. In this arti­cle, bsi is shar­ing insights on its per­spec­tive on how man­u­fac­tur­ers should look at the clin­i­cal eval­u­a­tion require­ments laid out in Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR).

The 19-page doc­u­ment pro­vides valu­able insights and also con­sid­ers guid­ance doc­u­ments that have been pub­lished by the Med­ical Device Coor­di­na­tion group (MDCG).

The arti­cle is pub­licly avail­able and may be down­loaded from bsi’s website.

Source: bsi 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

Browse our website’s con­tent by key­word “Clin­i­cal Evaluation”