Struc­tured dia­logues and exist­ing information

The Med­ical Device Coor­di­na­tion Group (MDCG) issued a new revi­sion of MDCG 2019-6, Ques­tions and answers: Require­ments relat­ing to noti­fied bod­ies. In revi­sion 5, cer­tain ques­tions have been added or updat­ed. Impor­tant­ly, sec­tion I.6 has been replaced by sec­tions I.6.1 to I.6.3. This sec­tion lays out the details regard­ing struc­tured dia­logues with noti­fied bod­ies. This process is essen­tial to under­stand for man­u­fac­tur­ers as struc­tured dia­logues are intend­ed to help clar­i­fy­ing impor­tant ques­tions on a device’s con­for­mi­ty assess­ment pro­ce­dure upfront and thus safe­guard a smoother cer­ti­fi­ca­tion. Fur­ther­more, there are new details as to how exist­ing infor­ma­tion may be used to pre­vent dupli­cate work at noti­fied bod­ies and manufacturers.

Arti­cle 10a, MDR and IVDR

Arti­cle 10a of the med­ical devices and in vit­ro diag­nos­tic med­ical devices reg­u­la­tion (MDR and IVDR) was set up in the con­text of amend­ing Reg­u­la­tion (EU) 2024/1860. It came into effect by Jan­u­ary 10, 2025 and oblig­es man­u­fac­tur­ers to inform in the event of a sup­ply inter­rup­tion or dis­con­tin­u­a­tion. The Euro­pean Com­mis­sion has pub­lished a Q&A doc­u­ment and addi­tion­al report­ing forms. What was miss­ing up so far is a deci­sion flow chart. MedTech Europe has now set up a deci­sion tree for man­u­fac­tur­ers to “under­stand, inter­pret, and apply Arti­cle 10a MDR/IVDR in prac­tice.” The doc­u­ment can be down­loaded here.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website