ISO TR 20416 and PMS under the MDR

Accord­ing to arti­cle 84 and annex III of Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR), man­u­fac­tur­ers must draw up a Post-Mar­ket Sur­veil­lance (PMS) Plan.

As men­tioned in pre­vi­ous arti­cles, PMS takes an essen­tial role in the MDR and is cross linked with risk man­age­ment, clin­i­cal eval­u­a­tion and oth­er cru­cial process­es. Man­u­fac­tur­ers should thus make sure that the cor­re­spond­ing require­ments are fulfilled.

As with oth­er main top­ics, the Euro­pean Com­mis­sion falls short of expec­ta­tions to pub­lish use­ful guid­ance doc­u­ments in a time­ly manner. 

Recent­ly, the ISO TR 20416 doc­u­ment was issued. It is intend­ed to help man­u­fac­tur­ers set­ting up a PMS sys­tem. Experts con­sid­er the report a use­ful sup­port­ing doc­u­ment to also com­ply with the cor­re­spond­ing MDR requirements.

Source: ISO

To receive fur­ther infor­ma­tion on this sub­ject, please notice the fol­low­ing articles

• Para­graph “Major aspects of the MDR”.
• Arti­cle “Most impor­tant changes on MDR“.
• Arti­cle Tech­ni­cal Doc­u­men­ta­tion Require­ments under the MDR – a Case Study.
• Arti­cle New MDR and IVDR check­lists for PMS and Dec­la­ra­tion of Con­for­mi­ty.