The Med­ical Device Coor­di­na­tion Group (MDCG) has issued a guid­ance doc­u­ment MDCG 2021-7 for man­u­fac­tur­ers of in vit­ro diag­nos­tic med­ical devices that relate to SARS-CoV-2.

The scope is defined as follows:

“This notice is addressed to man­u­fac­tur­ers of in vit­ro diag­nos­tic med­ical devices (IVDs) with the intend­ed pur­pose to detect and/or quan­ti­fy mark­ers of SARS-CoV-2 infec­tion, as well as their autho­rised rep­re­sen­ta­tives. The notice under­lines the man­u­fac­tur­ers’ respon­si­bil­i­ties to con­tin­u­al­ly assess the impact of new­ly iden­ti­fied genet­ic vari­ants of SARS-CoV-2 on the capa­bil­i­ty of those IVDs to meet their per­for­mance, risk and safe­ty claims.”

Among oth­ers, man­u­fac­tur­ers are required to con­tin­u­al­ly assess the impact that new genet­ic vari­ants may have, to ensure that the per­for­mance of their devices con­tin­ues to meet the essen­tial require­ments set out in the IVDD.

Man­u­fac­tur­ers should review the guid­ance doc­u­ment in detail and make sure that the cor­re­spond­ing require­ments are fulfilled. 

Source: Euro­pean Commission

For fur­ther in depth infor­ma­tion on this sub­ject we rec­om­mend the fol­low­ing arti­cles on our website