The World Health Organ­i­sa­tion has said that COVID-19 is no longer a world-wide urgent health sit­u­a­tion. What does this mean for the future reg­u­la­tion of COVID-19 tests in the con­text of Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR)?

When the Euro­pean Com­mis­sion released a Q&A doc­u­ment on COVID-19 tests in Feb­ru­ary 2021 it announced that COVID-19 IVD tests will as a rule be clas­si­fied in the high­est risk class, but an anno­ta­tion says that the clas­si­fi­ca­tion hinges on the intend­ed pur­pose as declared by the manufacturer. 

Some ques­tion if COVID-19 tests should be in the high­est risk clas­si­fi­ca­tion now that it is deemed mere­ly as a recog­nised and con­tin­u­ing health mat­ter and no longer a world-wide health emer­gency. The answer is deci­sive in when lega­cy COVID-19 prod­ucts mov­ing around on the mar­ket must com­ply with IVDR. In the wake of the pub­li­ca­tion of the IVDR amend­ing reg­u­la­tion, lega­cy class D IVD med­ical devices now have to com­ply with the IVDR by 26 May 2025. How­ev­er, if COVID-19 tests are regard­ed as mod­er­ate risk now, they would have an extra year or two to comply. 

Source: Medtech Insight (an Infor­ma product)

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