The Med­ical Device Coor­di­na­tion Group (MDCG) has issued a draft Q&A doc­u­ment clar­i­fy­ing the oblig­a­tions for Man­u­fac­tur­er Trend Report­ing (MTR) under Arti­cle 88 of the med­ical devices reg­u­la­tion (MDR) and Arti­cle 83 of the in vit­ro diag­nos­tic med­ical devices reg­u­la­tion (IVDR). Its aim is to har­monise vig­i­lance prac­tices across the EU and ensure that man­u­fac­tur­ers, noti­fied bod­ies, and com­pe­tent author­i­ties apply con­sis­tent cri­te­ria when iden­ti­fy­ing and report­ing sig­nif­i­cant increas­es in device-relat­ed incidents. 

Scope of reporting

The guid­ance explains when a report is required, high­light­ing that both increas­es in fre­quen­cy and sever­i­ty of inci­dents may trig­ger report­ing. It also clar­i­fies that the require­ment can apply to indi­vid­ual devices, prod­uct groups, and, in some cas­es, glob­al datasets. To ensure con­sis­ten­cy, the doc­u­ment sets out expec­ta­tions for defin­ing “sta­tis­ti­cal sig­nif­i­cance,” pro­vid­ing exam­ples of suit­able method­olo­gies, and stress­ing the need to jus­ti­fy base­lines and obser­va­tion periods.

Man­u­fac­tur­er responsibilities

Man­u­fac­tur­ers are remind­ed that trend report­ing is not a stand­alone exer­cise but part of the post-mar­ket sur­veil­lance sys­tem. An MTR sub­mis­sion should include the des­ig­nat­ed form togeth­er with a sup­port­ing Trend Report doc­u­ment. Actions may fol­low from iden­ti­fied trends, includ­ing deep­er inves­ti­ga­tions, updates to the benefit–risk pro­file, post-mar­ket sur­veil­lance adjust­ments, and where nec­es­sary, cor­rec­tive actions or field safe­ty measures.

EUDAMED & prac­ti­cal guidance

The Q&A also offers prac­ti­cal guid­ance on how to han­dle sub­mis­sions in EUDAMED, includ­ing the fields to com­plete and require­ments for fol­low-up reports. By pro­vid­ing illus­tra­tive exam­ples and address­ing com­mon scenarios—such as new event types or expand­ed device scope—the doc­u­ment makes the oblig­a­tions more operational.

We would like to note that the doc­u­ment is still in its draft form and when pub­lished, it will be non-bind­ing. Nonethe­less, the Q&A pro­vides an impor­tant out­look regard­ing expec­ta­tions of author­i­ties towards manufacturers.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website