Key guid­ance doc­u­ment on the clas­si­fi­ca­tion of IVDs under the IVDR

The Euro­pean Com­mis­sion has pub­lished a key guid­ance doc­u­ment on the clas­si­fi­ca­tion of in vit­ro diag­nos­tic med­ical device (IVD) under Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) to give advice to man­u­fac­tur­ers, noti­fied bod­ies, health orga­ni­za­tions and oth­er stake­hold­ers on how to clas­si­fy an IVD. 

The doc­u­ment gives detailed clar­i­fi­ca­tion on the sev­en IVD clas­si­fi­ca­tion rules, as spec­i­fied in annex VIII of the IVDR. It pro­vides the under­ly­ing prin­ci­ple and exam­ples for demon­stra­tive pur­pos­es. It also explains the indents in the rules and includes an annex with illus­tra­tive examples.

Man­u­fac­tur­ers of IVDs are high­ly rec­om­mend­ed to review the doc­u­ment in detail to get famil­iar with the log­ic behind the new IVDR clas­si­fi­ca­tion system.

Source: Medtech Insight (an Infor­ma product)

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