Man­u­fac­tur­ers of lega­cy in vit­ro diag­nos­tic (IVD) med­ical devices clas­si­fied as class C under the EU In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR) face two crit­i­cal upcom­ing dead­lines — and miss­ing either one risks los­ing the right to con­tin­ue plac­ing prod­ucts on the EU mar­ket until 31 Decem­ber 2028.

Under Arti­cle 110(3c) IVDR, man­u­fac­tur­ers of class C devices pre­vi­ous­ly self-cer­ti­fied under Direc­tive 98/79/EC (IVDD) must:

Both con­di­tions — along with require­ments such as IVDR QMS com­pli­ance and con­tin­ued adher­ence to the IVDD — must be met for the tran­si­tion­al pro­vi­sions to apply.

Prac­ti­cal take­away: If you have not yet iden­ti­fied and engaged a des­ig­nat­ed NB, do so imme­di­ate­ly. NB capac­i­ty remains con­strained, and fail­ing to meet the May 2026 appli­ca­tion dead­line will dis­qual­i­fy your prod­ucts from the tran­si­tion­al path­way regard­less of sub­se­quent steps.

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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