Back in Sep­tem­ber, the Euro­pean Com­mis­sion pub­lished its third revi­sion of the 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 man­u­al includes deci­sions and ratio­nales for prod­ucts where the clas­si­fi­ca­tion as a med­ical device or the cor­re­spond­ing risk class respec­tive­ly is not entire­ly clear. It is a help­ful doc­u­ment that may pro­vide valu­able insights on how the reg­u­la­to­ry author­i­ties in Europe look at cer­tain device types.

Should you be inter­est­ed in the bor­der­line man­u­al, please don’t hes­i­tate to let us know and we will pro­vide you with a copy. You can also down­load your ver­sion under our library sec­tion.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website