Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) is not even three months away and the des­ig­na­tion of Noti­fied Bod­ies is still behind the expec­ta­tions of the indus­try and the announce­ments made by the Euro­pean Commission.

The last body that has been des­ig­nat­ed under the MDR is the Nation­al Stan­dards Author­i­ty of Ire­land (NSAI). Man­u­fac­tur­ers may now choose between 11 orga­ni­za­tions.

Under Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR), still only three bod­ies have been des­ig­nat­ed so far.

Source: NANDO database

Do you want to find out more regard­ing Noti­fied Bodies?

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