EN 1041:2008 is the har­mo­nized stan­dard for infor­ma­tion to be sup­plied by med­ical device manufacturers.

The Inter­na­tion­al Stan­dard­iza­tion Orga­ni­za­tion (ISO) has recent­ly pub­lished ISO 20417:2021, which will replace EN 1041 under Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR). 

As com­mu­ni­cat­ed in ear­li­er newslet­ter arti­cles, there are no har­monised stan­dards under the MDR and IVDR yet. Also gen­er­al­ly, the use of stan­dards is vol­un­tary. Nonethe­less, we antic­i­pate that com­pe­tent author­i­ties and noti­fied bod­ies will expect to a cer­tain degree that man­u­fac­tur­ers adopt this stan­dard in a time­ly manner. 

Source: Inter­na­tion­al Stan­dard­iza­tion Orga­ni­za­tion (ISO)

For fur­ther in depth infor­ma­tion on this sub­ject we rec­om­mend the fol­low­ing arti­cle on our website