Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices or in vit­ro diag­nos­tic med­ical devices respec­tive­ly (MDR and IVDR) form a dynam­ic reg­u­la­to­ry envi­ron­ment. Many guid­ance doc­u­ments and relat­ed arti­cles have been pub­lished through­out the past years and it appears chal­leng­ing to not lose track of recent changes. 

In this con­text, MDCG 2020-3 was pub­lished main­ly for man­u­fac­tur­ers of MDD lega­cy med­ical devices to pro­vide clar­i­ty on sig­nif­i­cant ver­sus non-sig­nif­i­cant changes. Only non-sig­nif­i­cant changes may be imple­ment­ed under the scope of an MDD cer­tifi­cate. The Med­ical Device Coor­di­na­tion Group has now updat­ed the doc­u­ment con­sid­er­ing the most recent exten­sion of the tran­si­tion peri­od or med­ical devices until 2027/ 2028.

Source: MDCG

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

Browse by key­word “Lega­cy Devices”