New guid­ance for third-coun­try man­u­fac­tur­ers of COVID-19 IVD tests

The Euro­pean Com­mis­sion attempts to fur­ther clar­i­fy its expec­ta­tions on IVD med­ical devices relat­ed to SARS-CoV-2 and its manufacturers.

In Jan­u­ary 2022, the Med­ical Device Coor­di­na­tion Group (MDCG) pub­lished MDCG 2022-1 titled “Notice to third coun­try man­u­fac­tur­ers of SARS-CoV-2 in vit­ro diag­nos­tic med­ical devices”. As the title says, the doc­u­ment tar­gets main­ly at man­u­fac­tur­ers of COVID-19 IVD tests out­side the EU.

MDCG 2022-1 lists among oth­ers the oblig­a­tion of these man­u­fac­tur­ers to appoint an EU Autho­rised Rep­re­sen­ta­tive, but also broach­es the top­ics of when to involve a noti­fied body, what are the trans­la­tion require­ments for labels and IFU and where impor­tant guid­ance can be found.

Final­ly, the guid­ance explains what should be regard­ed in terms of tran­si­tion to Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR).

Please let us know if you would like to have a copy of MDCG 2022-1 for your reference.

Source: Euro­pean Commission

For fur­ther infor­ma­tion on this subject 

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