The Euro­pean Med­i­cines Agency (EMA) pub­lished sci­en­tif­ic advice to the Med­ical Device Coor­di­na­tion Group (MDCG) with regards to the clas­si­fi­ca­tion of SARS-CoV-2 tests for in vit­ro diag­nos­tic (IVD) pur­pos­es. The advice was request­ed by the MDCG and pub­lished in Decem­ber 2024. Dur­ing the pan­dem­ic, SARS-CoV-2 tests tend­ed to be clas­si­fied under the high­est risk class D under the regime of the in vit­ro diag­nos­tic med­ical devices reg­u­la­tion (IVDR). After the pan­dem­ic, asso­ci­at­ed risk has less­ened significantly. 

The doc­u­ment pro­vides advice how SARS-CoV-2 tests should cur­rent­ly be con­sid­ered in light of the clas­si­fi­ca­tion cat­e­gories under the IVDR. Man­u­fac­tur­ers of the cor­re­spond­ing tests should take the doc­u­ment into account as this will have a major impact on the con­for­mi­ty assess­ment under the IVDR and the dura­tion of the tran­si­tion­al regime. The doc­u­ment can be accessed in the cor­re­spond­ing sec­tion of our website.

EMDN cod­ing

The MDCG issued a num­ber of doc­u­ments with regards to EMDN cod­ing. MDCG 2021-12, FAQ on the Euro­pean Med­ical Device Nomen­cla­ture (EMDN), was updat­ed with 18 new ques­tions and answers in revi­sion 1. Fur­ther­more, MDCG  2024-2, Pro­ce­dures for the updates of the Euro­pean Med­ical Device Nomen­cla­ture, was updat­ed. In addi­tion, the MDCG issued MDCG 2025-1 to MDCG 2025-3. These include forms for the appli­ca­tion of new EMDN codes as well as an overview of changes to the cur­rent codes. Should you require help in find­ing an appro­pri­ate code or apply for a new code, please let us know. The doc­u­ment can be accessed in the cor­re­spond­ing sec­tion of our website.

Source: EMA, Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website