MDCG Q&A doc­u­ment on vig­i­lance updated

The Med­ical Device Coor­di­na­tion Group (MDCG) issued MDCG 2023-3 on vig­i­lance back in 2023. The doc­u­ment was now updat­ed as rev. 1. Main changes relate to the con­sid­er­a­tion of Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) – the pre­vi­ous revi­sion only ref­er­enced and pro­vid­ed exam­ples for the MDR.

Nonethe­less, there are also new Q&A, for exam­ple how and to whom to report when pre­ven­tive or cor­rec­tive action becomes nec­es­sary due to find­ings in the manufacturer’s PMS system. 

The doc­u­ment can be accessed in the library sec­tion of our website. 

Source: MDCG

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website