Despite warn­ings about hold-ups at Noti­fied Bod­ies and prod­ucts fail­ing to be cer­ti­fied under the new Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 (IVDR) in time, the Euro­pean Com­mis­sion is con­fi­dent that things are on track.

The Euro­pean Com­mis­sion has declared that any reg­u­la­to­ry prob­lems which have appeared are resolv­able and that it is hap­py about the rate at which new struc­tures and guid­ance are being intro­duced and are con­fi­dent that there will be a ful­ly oper­a­tional EU sys­tem in place in May 2020. It said that there have been 39 appli­ca­tions by Noti­fied Bod­ies under the MDR and 10 under the IVDR and it is expect­ed the num­bers will increase as the dead­line gets near­er. New struc­tures, like expert pan­els, progress on prepar­ing forms, clar­i­fy­ing rules with mem­ber states and devel­op­ing guid­ance for all stake­hold­ers with the Med­ical Device Coor­di­na­tion Group (MDCG) will lessen the bur­den of work for Noti­fied Bodies. 

Oppo­site Posi­tion of MedTech Industry

The grace peri­od for MDD cer­tifi­cates is not the res­o­lu­tion to the Noti­fied Body bot­tle­neck.

Con­trary, indus­try insists that the new reg­u­la­to­ry sys­tem has to be oper­at­ing months before the dead­line to make sure that all the med­ical devices that are on the mar­ket at the moment can under­go a com­pul­so­ry 3-9 months re-cer­ti­fi­ca­tion process. The grace peri­od for MDD cer­tifi­cates is not the res­o­lu­tion to the pos­si­bil­i­ty that prod­ucts may not be cer­ti­fied under the new Reg­u­la­tion (2017/745) soon enough. The grace peri­od has two essen­tial flaws, the first being that numer­ous health-care-crit­i­cal prod­uct cat­e­gories are not enti­tled to the grace peri­od and no Euro­pean solu­tions have been offered to keep these devices avail­able after 26 May 2022 and sec­ond­ly, in real­i­ty, the grace peri­od for those med­ical devices that are eli­gi­ble will not func­tion because the cer­ti­fi­ca­tion groups are not able to process all the files ear­ly enough. 

Source: Medtech Insight (an Infor­ma prod­uct)