Noti­fied bod­ies are advis­ing man­u­fac­tur­ers to make their appli­ca­tions accord­ing to Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) imme­di­ate­ly, in par­tic­u­lar for class D IVDs or they are in dan­ger of non-com­pli­ance when the dead­lines arrive. The EU body indus­try asso­ci­a­tion, TEAM-NB has insist­ed on action for diag­nos­tics man­u­fac­tur­ers who need to com­ply with the IVDR to keep their prod­ucts on the mar­ket. Noti­fied bod­ies have the capac­i­ty to take on appli­ca­tions under the IVDR and accom­plish the con­for­mi­ty assess­ment process ear­ly enough if the appli­ca­tions are put for­ward at once. 

On the oth­er hand, if they are not sub­mit­ted in time, a noti­fied body can­not ensure that the con­for­mi­ty assess­ments and cer­ti­fi­ca­tions will be processed before the tran­si­tion time­lines come to an end. This could lead to prob­lems in the sup­ply chain and access to IVDs in the EU.

The Euro­pean Com­mis­sion print­ed the results of a sur­vey show­ing that the ini­tial con­for­mi­ty assess­ment process can take 6-12 months for low to medi­um risk devices (cov­ered by qual­i­ty annex cer­tifi­cates) and 13-18 months for high-risk devices (cov­ered by a prod­uct annex cer­tifi­cate). With this in mind, as well as the fact that the dead­line for class D devices is 26 May 2025 and the cur­rent time­lines for con­for­mi­ty assess­ment, it is vital for man­u­fac­tur­ers to con­tact a noti­fied body at once and sub­mit their appli­ca­tions right away. It is strong­ly advised to sub­mit the appli­ca­tions for class D devices before the end of this year, so that tech­ni­cal doc­u­men­ta­tion assess­ments can start ear­ly enough. 

Source: Medtech Insight (an Infor­ma product)

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