It seems that the medtech sys­tem is on course for calami­ty because NB des­ig­na­tion under the new EU Reg­u­la­tions 2017/745 and 2017/ 746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR) is so slow that a tail­back in NB reviews is certain. 

Con­se­quent­ly, some mem­ber state com­pe­tent author­i­ties are con­tem­plat­ing doing their own con­for­mi­ty assess­ments espe­cial­ly con­cen­trat­ing on the IVDR, since there have been only few appli­ca­tions for des­ig­na­tion as NBs, com­pared to the 22 NBs that present­ly are work­ing in this area under the the In Vit­ro Diag­nos­tic Med­ical Devices Direc­tive 98/79/EC (IVDD).

It is antic­i­pat­ed that there will be a huge demand in the num­ber of IVD com­pa­nies call­ing for NB input, because under the IVDR rough­ly 80-85% of prod­ucts will need the par­tic­i­pa­tion of a NB com­pared to about 10-15% cur­rent­ly. And to make mat­ters worse, some of these afore­men­tioned appli­cants may have to ter­mi­nate activ­i­ties because of Brexit. 

Man­u­fac­tur­ers have to do every­thing in their pow­er to com­ply with the MDR and IVDR now!

So far, any appeals from indus­try to the Euro­pean Com­mis­sion for a delay have been ignored and it has been told to get going with its ground­work and there will be no more allowances. 

Man­u­fac­tur­ers have to do every­thing in their pow­er to com­ply with the MDR and IVDR now, so they are not held respon­si­ble for any delay when the new EU medtech reg­u­la­to­ry sys­tem comes ful­ly into oper­a­tion on 26 May 2020 for med­ical devices and 26 May 2022 for IVDs. If, when the MDR or IVDR is ful­ly in oper­a­tion, com­pa­nies do not get a cer­tifi­cate for their prod­ucts through no fault of their own, it is pos­si­ble that new mea­sures will be found to keep these prod­ucts on the market.

To find more infor­ma­tion on this top­ic, you might read our arti­cle Noti­fied Body Selec­tion and Change or browse our arti­cles about Brex­it by Key­word.

Source: Medtech Insight (an Infor­ma product)