Back in August, we have issued an arti­cle about a new guid­ance doc­u­ment pub­lished by the Med­ical Device Coor­di­na­tion Group (MDCG), MDCG 2021-21. The guid­ance doc­u­ment lays out spe­cif­ic require­ments for the per­for­mance eval­u­a­tion of IVD tests relat­ed to SARS-CoV-2.

We would like to make affect­ed man­u­fac­tur­ers aware again of the impor­tance of this guid­ance doc­u­ment. Under the cur­rent IVD Direc­tive (IVDD), the includ­ed pro­vi­sions are vol­un­tary as long as a good jus­ti­fi­ca­tion is in place to not fol­low the guidance. 

How­ev­er, the doc­u­ment also says that the Com­mis­sion con­sid­ers adopt­ing the includ­ed pro­vi­sions as com­mon spec­i­fi­ca­tions under Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR). Com­mon spec­i­fi­ca­tions also have a vol­un­tary char­ac­ter, but in prac­tice it is expect­ed it will be impos­si­ble to jus­ti­fy an alter­na­tive approach. 

As a con­se­quence, man­u­fac­tur­ers should ensure to com­ply with the guid­ance require­ments also in prepa­ra­tion for the IVDR. SARS-CoV-2 tests will have to ful­ly com­ply to the IVDR by May 26, 2022 and tend to fall into the high­est risk class D with a much high­er lev­el of scruti­ny includ­ing cer­ti­fi­ca­tion by a noti­fied body. 

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website