The Med­ical Device Coor­di­na­tion Group (MDCG) has updat­ed its guid­ance doc­u­ment MDCG 2021-4, Appli­ca­tion of tran­si­tion­al pro­vi­sions for cer­ti­fi­ca­tion of class D in vit­ro diag­nos­tic med­ical devices accord­ing to Reg­u­la­tion (EU) 2017/746 (IVDR). 

The doc­u­ment includes among oth­ers edi­to­r­i­al changes, but also a new Q&A sec­tion. The guid­ance doc­u­ment gen­er­al­ly pro­vides advice for man­u­fac­tur­ers of class D in vit­ro diag­nos­tic med­ical devices for how to apply the IVDR pro­vi­sions relat­ed to expert pan­els and EU ref­er­ence lab­o­ra­to­ries (EURLs) before the IVDR appli­ca­tion date, i.e. 26 May 2022, as well as around the time when the first EURL des­ig­na­tions become applic­a­ble for the pur­pose of EURL tasks. 

You may access the guid­ance doc­u­ment here. 

Source: Euro­pean Commission

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