Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) is ful­ly applic­a­ble since May 26, 2022. The IVDR is con­sid­ered a game chang­er for the med­ical device indus­try. The bad news is, that the new legal frame­work brings com­pre­hen­sive changes in sev­er­al aspects and increas­es hur­dles for man­u­fac­tur­ers and oth­er eco­nom­ic oper­a­tors before prod­ucts may be placed on the mar­ket. The good news is, that mdi Europa can pro­vide you with exper­tise and guid­ance for your trans­for­ma­tion process.

The four major aspects that are affect­ed by the IVDR

1. Clas­si­fi­ca­tion changes

he IVDR intro­duces a risk-based clas­si­fi­ca­tion sys­tem sim­i­lar to the MDR. Risk class­es range from A to D (A being the low­est and D the high­est risk class). Class B, C and D prod­ucts require the involve­ment of a Noti­fied Body

2. Gen­er­al safe­ty and per­for­mance requirements

The IVDR intro­duces a new set of require­ments, which will replace the pre­vi­ous essen­tial require­ments. These will also include many points that have been ref­er­enced in guid­ance doc­u­ments and stan­dards under the in vit­ro diag­nos­tic med­ical devices direc­tive (IVDD).

3. UDI/ EUDAMED

The IVDR intro­duces new trace­abil­i­ty mech­a­nisms includ­ing unique device iden­ti­fi­ca­tion (UDI) and com­pre­hen­sive changes in the reg­is­tra­tion require­ments for devices and eco­nom­ic operators.

4. Clin­i­cal evaluation

The require­ments on the per­for­mance eval­u­a­tion process have been sub­stan­ti­at­ed and fur­ther refined. Suf­fi­cient clin­i­cal evi­dence must be gen­er­at­ed con­sid­er­ing sci­en­tif­ic valid­i­ty, ana­lyt­i­cal per­for­mance and clin­i­cal per­for­mance. 

But there is still more to learn in the new reg­u­la­to­ry reality

We have guid­ed near­ly all of our clients already suc­cess­ful­ly through their trans­for­ma­tion process and like to offer you our support.

Feel free to take a look at the dif­fer­ent con­tri­bu­tions which we are pro­vid­ing for you in our exten­sive web­site con­tent regard­ing the IVDR. If there are any spe­cif­ic areas of con­cern or inter­est above that, don’t hes­i­tate and get in touch with us.

We also rec­om­mend the web­site of the Euro­pean Com­mis­sion as a valu­able source of infor­ma­tion for man­u­fac­tur­ers of med­ical devices world­wide. Feel free to use the fol­low­ing image as a direct link.

The web­site of the Euro­pean Com­mis­sion is a valu­able source of infor­ma­tion for man­u­fac­tur­ers of med­ical devices worldwide