IVD med­ical devices after the IVDR date of application 

Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) will become ful­ly applic­a­ble on May 26, 2022. In this con­text, we would like to draw the reader’s atten­tion to some very impor­tant points:

• All class A med­ical devices must be ful­ly com­pli­ant to the IVDR by May 26, 2022. Exempt­ed from full IVDR com­pli­ance are prod­ucts that will require noti­fied body involve­ment due to amend­ed IVDR clas­si­fi­ca­tion rules and that hold a valid IVDD CE certificate. 
• Devices requir­ing full IVDR com­pli­ance as per the state­ment above that have not com­plet­ed the cor­re­spond­ing IVDR con­for­mi­ty assess­ment pro­ce­dure may not be placed on the mar­ket after May 25, 2022. 
• IVD med­ical devices that may con­tin­ue to be placed on the mar­ket under the IVDD beyond May 26, 2022 in accor­dance with arti­cle 110 of the IVDR, may only be sold under cer­tain con­di­tions. Please watch out for guid­ance doc­u­ments that we expect to see released soon. We would advise to regard MDR guid­ance doc­u­ments MDCG 2020-2 and MDCG 2020-3 in the interim.

Should you have any ques­tions or con­cerns in this con­text, please don’t hes­i­tate to get in touch.

Source: IVDR

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Euro­pean Com­mis­sion pro­pos­al for pro­gres­sive roll-out of the IVDR adopted
• SARS-CoV-2 IVD tests and the IVDR
• The IVDR and per­for­mance eval­u­a­tion studies