A sub­group of the Med­ical Device Coor­di­na­tion Group (MDCG) pub­lished its first bor­der­line man­u­al under the med­ical device reg­u­la­tions titled “Man­u­al on bor­der­line and clas­si­fi­ca­tion for med­ical devices under Reg­u­la­tion (EU) 2017/745 on med­ical devices and Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices”. The doc­u­ment describes the under­stand­ing of mem­ber state com­pe­tent author­i­ties regard­ing the def­i­n­i­tion and clas­si­fi­ca­tion of med­ical devices on dis­putable cases. 

Noti­fied body bsi has recent­ly pub­lished a white paper that dis­cuss­es the require­ments under Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) regard­ing per­for­mance eval­u­a­tions. The 27-page doc­u­ment gives valu­able insights how cer­ti­fy­ing par­ties view the IVDR require­ments and how to best cope with them. As the per­for­mance eval­u­a­tion process is a cen­tral one and IVDR require­ments have been expand­ed com­pared the IVD Direc­tive, the paper is high­ly rec­om­mend­able for man­u­fac­tur­ers of IVD med­ical devices. 

Source: MDCG, bsi

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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