The Euro­pean Com­mis­sion is con­tin­u­ing efforts to des­ig­nate addi­tion­al Noti­fied Bod­ies under the new Reg­u­la­tions. More recent­ly, bsi Nether­lands and DARE!! Ser­vices have both been des­ig­nat­ed under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR). Both are list­ed in the NANDO database.

In addi­tion, bsi UK has been appoint­ed under Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) as the sec­ond Noti­fied Body.

With nine orga­ni­za­tions des­ig­nat­ed, it remains unclear if the goal of the Euro­pean Com­mis­sion to list 20 cer­ti­fy­ing bod­ies until the end of the year will be achieved. 

Man­u­fac­tur­ers and oth­er inter­est­ed par­ties are advised to check the NANDO data­base for updates regularly. 

Source: NANDO database

Want to find out more regard­ing Noti­fied Bodies?

You might read our arti­cle Noti­fied Body Selec­tion and Change or browse our arti­cles by key­word Noti­fied Body.