The Euro­pean Com­mis­sion has fall­en behind when it comes to pro­vid­ing guid­ance and struc­tures required to sup­port the in vit­ro med­ical devices sec­tor in time­ly com­pli­ance with Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) caus­ing fears that safe prod­ucts will have to be tak­en off the market.

Noti­fied Bod­ies have a dif­fi­cult chal­lenge ahead try­ing to man­age the demand that is com­ing from IVD med­ical device man­u­fac­tur­ers who are look­ing for audits under the IVDR. This is as a result of about 80% of IVD prod­ucts being reclas­si­fied from the IVD Direc­tive (IVDD), where a Noti­fied Body was rarely involved, into a risk class, B, C or D under the IVDR, where a Noti­fied Body is mandatory. 

There are still many struc­tures not in place for IVD devices, chiefly the Euro­pean ref­er­ence lab­o­ra­to­ries and expert pan­els nec­es­sary for class D IVD prod­ucts. The sec­tor also requires more Noti­fied Bod­ies des­ig­nat­ed against the IVDR. At the moment there are only 4 com­pared with 22 under the IVDD, where only about 10% of prod­ucts require a Noti­fied Body. 

It is also vital that the required guid­ance to sup­port com­pli­ance with the IVDR comes as quick­ly as pos­si­ble. Regard­ing, for exam­ple, com­pan­ion diag­nos­tics, which fall chiefly into Class C, guid­ance is urgent­ly required due to the length of time need­ed for com­pa­nies and Noti­fied Bod­ies to adjust to that guidance. 

Source: Medtech Insight (an Infor­ma product)

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