The Euro­pean Com­mis­sion has released Revi­sion 2 of its Q&A doc­u­ment on arti­cle 10a of the EU Med­ical Device Reg­u­la­tion (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR), which gov­erns man­u­fac­tur­ers’ oblig­a­tions to inform com­pe­tent author­i­ties and health insti­tu­tions when a device sup­ply inter­rup­tion or dis­con­tin­u­a­tion is antic­i­pat­ed. Along­side the updat­ed Q&A, a prac­ti­cal deci­sion tree — devel­oped by Euro­pean com­pe­tent author­i­ties — has been for­mal­ly ref­er­enced for the first time, offer­ing man­u­fac­tur­ers a struc­tured tool to assess whether a noti­fi­ca­tion oblig­a­tion is trig­gered in a giv­en situation.

Back­ground: What arti­cle 10a requires

Arti­cle 10a was intro­duced into both the MDR and IVDR by Reg­u­la­tion (EU) 2024/1860, which amend­ed the two reg­u­la­tions to address, among oth­er mat­ters, sup­ply chain resilience for med­ical devices. The arti­cle estab­lish­es a proac­tive noti­fi­ca­tion duty: where a man­u­fac­tur­er antic­i­pates an inter­rup­tion or per­ma­nent dis­con­tin­u­a­tion of sup­ply that could have a sig­nif­i­cant impact on patient care, it must inform both the rel­e­vant com­pe­tent author­i­ty and, where applic­a­ble, health insti­tu­tions in a time­ly man­ner. The intent is to give health­care sys­tems suf­fi­cient lead time to source alter­na­tives and mit­i­gate risks to patients.

The Commission’s Q&A doc­u­ment serves as the pri­ma­ry inter­pre­tive guid­ance for this pro­vi­sion, address­ing prac­ti­cal ques­tions around scope, time­lines, thresh­olds, and pro­ce­dur­al requirements.

What’s new in revi­sion 2

The most sig­nif­i­cant change in the updat­ed Q&A is the addi­tion of Ques­tion 9.2, which for­mal­ly ref­er­ences a deci­sion tree dia­gram devel­oped by Euro­pean com­pe­tent author­i­ties. This visu­al tool is designed to help man­u­fac­tur­ers sys­tem­at­i­cal­ly work through the cri­te­ria that deter­mine whether a noti­fi­ca­tion oblig­a­tion aris­es — a par­tic­u­lar­ly wel­come addi­tion giv­en the nuanced, case-by-case nature of arti­cle 10a assessments.

By embed­ding this tool with­in the offi­cial Q&A frame­work, the Com­mis­sion has effec­tive­ly ele­vat­ed it from a com­pe­tent author­i­ty work­ing aid to a doc­u­ment that man­u­fac­tur­ers can — and should — ref­er­ence in their inter­nal com­pli­ance processes.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website