MedTech indus­try is des­per­ate­ly wait­ing for more Noti­fied Bod­ies to be des­ig­nat­ed under the MDR and IVDR. Two more orga­ni­za­tions have now been appointed. 

You may already have heard the rumors before – but with the name being pub­lished on the NANDO data­base, TÜV Rhein­land LGA Prod­ucts GmbH has offi­cial­ly been des­ig­nat­ed under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR). 

Man­u­fac­tur­ers may now choose between five Noti­fied Bod­ies that are autho­rized to issue CE cer­tifi­cates under the MDR. Although slow­ly increas­ing, the num­ber falls short of the orga­ni­za­tions that are cur­rent­ly des­ig­nat­ed under the Med­ical Devices Direc­tive 93/42/EEC (MDD) and Active Implantable Med­ical Devices Direc­tive 90/385/EEC (AIMDD). 

In addi­tion, the first Noti­fied Body, DEKRA Cer­ti­fi­ca­tion GmbH from Ger­many, has been appoint­ed under Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR). It goes with­out say­ing that fur­ther assign­ments are des­per­ate­ly need­ed for the IVDR as well. 

Want to find out more regard­ing Noti­fied Bodies?

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