Per­for­mance eval­u­a­tions will take an inte­gral part in the CE Mark­ing process of in vit­ro diag­nos­tic med­ical devices under the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR). This arti­cle out­lines, which guid­ance doc­u­ments pub­lished by the Inter­na­tion­al Med­ical Device Reg­u­la­tors Forum (IMDRF) man­u­fac­tur­ers may use already now to facil­i­tate com­pli­ance to the IVDR. 

Dra­mat­ic Impact on Man­u­fac­tur­ers of In Vit­ro Diag­nos­tic Med­ical Devices

At present, the reg­u­la­to­ry dis­cus­sion in Europe pret­ty much focus­es on Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR). It seems eas­i­ly for­got­ten that the impact of Reg­u­la­tion (EU) 2017/746 on in vit­ro med­ical devices (IVDR) on indus­try is expect­ed to be much more dramatic.

Also, man­u­fac­tur­ers of IVD prod­ucts should do what­ev­er they can to pre­pare them­selves for the com­ing date of full appli­ca­tion in May 2022. A point that will be espe­cial­ly crit­i­cal against this back­ground, is the per­for­mance eval­u­a­tion. The per­for­mance eval­u­a­tion refers to a process in which a man­u­fac­tur­er must estab­lish the sci­en­tif­ic valid­i­ty and the ana­lyt­i­cal and clin­i­cal per­for­mance of a prod­uct wher­ev­er that is applicable.

Guid­ance Doc­u­ments issued by the IMDRF

mdi Europa has com­piled a tem­plate doc­u­ment that may be pur­chased sep­a­rate­ly to sup­port your tran­si­tion process.

Although no offi­cial guid­ance doc­u­ment has been pub­lished by the Euro­pean Com­mis­sion, the Inter­na­tion­al Med­ical Device Reg­u­la­tors Forum (IMDRF, for­mer­ly Glob­al Har­mo­niza­tion Task Force – GHTF) issued the guid­ance doc­u­ments GHTF/SG5/N6:2012 (Clin­i­cal Evi­dence for IVD Med­ical Devices), GHTF/SG5/N7:2012 (Sci­en­tif­ic Valid­i­ty Deter­mi­na­tion and Per­for­mance Eval­u­a­tion) and GHTF/SG5/N8:2012 (Clin­i­cal Per­for­mance Stud­ies for IVD Med­ical devices. These may be used to estab­lish a good basis for the IVDR require­ments. In this con­text, the IVDR also ref­er­ences to stan­dard ISO 20916:2019 on clin­i­cal per­for­mance stud­ies con­cern­ing IVD devices.

Please note: you will find the required down­loads, links and more at the end of this article!

Fur­ther­more, please note that mdi Europa has com­piled a tem­plate doc­u­ment that may be pur­chased sep­a­rate­ly to sup­port your tran­si­tion process. Should you require addi­tion­al infor­ma­tion, please don’t hes­i­tate to get in touch. 

Sources: IMDRF, ISO, IVDR

Guid­ance doc­u­ments regard­ing the IVDR issued by the Inter­na­tion­al Med­ical Device Reg­u­la­tors Forum for download

GHTF/SG5/N6:2012 (Clin­i­cal Evi­dence for IVD Med­ical Devices) [PDF 327 KB]
GHTF/SG5/N7:2012 (Sci­en­tif­ic Valid­i­ty Deter­mi­na­tion and Per­for­mance Eval­u­a­tion) [PDF 769 KB]
GHTF/SG5/N8:2012 (Clin­i­cal Per­for­mance Stud­ies for IVD Med­ical devices [PDF 434 KB]

Clin­i­cal per­for­mance stud­ies con­cern­ing IVD devices

Vis­it web­site www.iso.org.

Help­ful links and down­loads regard­ing the IVDR on our website 

Vis­it our page “Major Aspects of the IVDR”.
Check our Guid­ance Doc­u­ments regard­ing the IVDR.
Read our Sup­port­ive Infor­ma­tion Sec­tion regard­ing the IVDR.