A 31-page guid­ance doc­u­ment, MDCG 2022-2 on the gen­er­al con­cept of how to col­lect and sus­tain clin­i­cal evi­dence for in vit­ro diag­nos­tic (IVD) med­ical devices under Reg­u­la­tion (EU) 2017/746 (IVDR) has been pub­lished in the con­text of the com­ing date of appli­ca­tion of the new reg­u­la­tion on 26 May this year. 

The doc­u­ment empha­sis­es that per­for­mance eval­u­a­tion should be an on-going process to pro­duce and sus­tain the clin­i­cal evi­dence required to sup­port an IVD med­ical device’s intend­ed pur­pose and that a life­cy­cle approach must be intro­duced which involves clin­i­cal evi­dence being updat­ed right through the device’s lifecycle. 

The guid­ance also describes how to com­pile, gen­er­ate and record the sup­port­ing data for an IVD med­ical device and declares that risks and risk con­trol pro­ce­dures should be reflect­ed in the per­for­mance eval­u­a­tion process for the device in keep­ing with an up-to-date life­cy­cle approach. 

MDCG 2022-2 stress­es that risk clas­si­fi­ca­tion is not the only fea­ture which influ­ences the lev­el of clin­i­cal evi­dence required. As a gen­er­al rule, sci­en­tif­i­cal­ly sub­stan­ti­at­ed con­clu­sions should be made by using a sys­tem­at­ic and explic­it appraisal of date that sup­ports deci­sions made and con­clu­sions reached regard­ing suf­fi­cient clin­i­cal evi­dence. 

Man­u­fac­tur­ers are high­ly encour­aged to care­ful­ly review the guid­ance document. 

Source: Medtech Insight (an Infor­ma prod­uct), Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website