The Euro­pean Com­mis­sion adopt­ed Imple­ment­ing Reg­u­la­tion (EU) 1022/ 1107. It is out­lin­ing the Com­mon Spec­i­fi­ca­tions (CS) for cer­tain class D IVD med­ical devices (includ­ing SARS-CoV-2 tests) in the con­text of Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tics med­ical devices (IVDR). 

Class D is the high­est risk class under the IVDR, and lega­cy IVD med­ical devices that will under class D under the IVDR must abide by the new rules by 26 May 2025. New class D prod­ucts had to sat­is­fy IVDR require­ments by 26 May this year, and the absence of these miss­ing CS trig­gered con­fu­sion and tur­moil among both man­u­fac­tur­ers and noti­fied bodies. 

The present CS con­cen­trate main­ly on IVD per­for­mance fea­tures and con­sists of two parts. The first five-page long part high­lights ratio­nale, def­i­n­i­tions, tran­si­tion­al pro­vi­sions and time­lines. The sec­ond 63-page tech­ni­cal part includes the pro­posed CS. It also out­lines, in an Annex I the gen­er­al require­ments for per­for­mance char­ac­ter­is­tics for all IVDs that are sort­ed out in the respec­tive annexes. 

Twelve addi­tion­al annex­es spell out the CS for IVDs designed for detec­tion, and some­times quan­tifi­ca­tion, of:

AnnexType of Class D IVD
IIBlood group anti­gens in the ABO, Rhe­sus, Kell, Duffy and Kidd blood group systems
IIIHuman immun­od­e­fi­cien­cy virus (HIV) infec­tion markers
IVHuman T-cell lym­photrop­ic virus (HTLV) infec­tion markers
VHepati­tis C virus (HCV) infec­tion markers
VIHepati­tis B virus (HBV) infec­tion markers
VIIHepati­tis D virus (HDV) infec­tion markers
VIIIVari­ant Creutzfeldt-Jakob dis­ease (vCJD) markers
IXEpstein-Barr virus infec­tion (EBV) markers
XTre­pone­ma pal­lidum infec­tion markers
XITry­panoso­ma cruzi infec­tion markers
XIISevere acute res­pi­ra­to­ry syn­drome coro­n­avirus 2 (SARS-CoV-2) infec­tion markers

The Imple­ment­ing Reg­u­la­tion will take effect on the 20th day after pub­li­ca­tion in the Offi­cial Jour­nal of the Euro­pean Union (OJEU) and will be ful­ly imple­ment­ed from 25 July 2024. 

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

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website