The Euro­pean Com­mis­sion has issued new guid­ance doc­u­ments that con­cern the activ­i­ties of noti­fied bod­ies under Reg­u­la­tions (EU) 2017/745 and 2017/746 (MDR and IVDR).

These guid­ance doc­u­ments are intend­ed for noti­fied bod­ies. We would nev­er­the­less strong­ly sug­gest man­u­fac­tur­ers to review the guid­ance to obtain a bet­ter pic­ture of review and sur­veil­lance prac­tices among noti­fied bodies.

Source: MDCG

Author: Oliv­er

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website