The Euro­pean Com­mis­sion has released MDCG 2020-16 rev.4, an updat­ed guid­ance doc­u­ment on the clas­si­fi­ca­tion of in vit­ro diag­nos­tic med­ical devices under Reg­u­la­tion (EU) 2017/746. This revi­sion intro­duces key changes to improve reg­u­la­to­ry clar­i­ty and refine clas­si­fi­ca­tion rules.

One notable update is the reclas­si­fi­ca­tion of SARS-CoV-2 tests: self-tests are now cat­e­go­rized as Class C, while tests for pro­fes­sion­al use fall under Class B. Addi­tion­al­ly, exam­ples for var­i­ous clas­si­fi­ca­tion rules, includ­ing Rule 1, Rule 4, and Rule 6, have been revised.

These adjust­ments aim to help man­u­fac­tur­ers align their prod­ucts with the lat­est reg­u­la­to­ry require­ments. Com­pa­nies plac­ing in vit­ro diag­nos­tics on the EU mar­ket should care­ful­ly review the new guide­lines to ensure com­pli­ance with the updat­ed clas­si­fi­ca­tion rules, espe­cial­ly when con­sid­er­ing the extend­ed tran­si­tion peri­od.

More details on the new ver­sion of the MDCG guid­ance can be found in our Library section.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website