EU’s Imple­ment­ing Reg­u­la­tion on Com­mon Spec­i­fi­ca­tions for class D IVDs

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:

Annex	Type of Class D IVD
II	Blood group anti­gens in the ABO, Rhe­sus, Kell, Duffy and Kidd blood group systems
III	Human immun­od­e­fi­cien­cy virus (HIV) infec­tion markers
IV	Human T-cell lym­photrop­ic virus (HTLV) infec­tion markers
V	Hepati­tis C virus (HCV) infec­tion markers
VI	Hepati­tis B virus (HBV) infec­tion markers
VII	Hepati­tis D virus (HDV) infec­tion markers
VIII	Vari­ant Creutzfeldt-Jakob dis­ease (vCJD) markers
IX	Epstein-Barr virus infec­tion (EBV) markers
X	Tre­pone­ma pal­lidum infec­tion markers
XI	Try­panoso­ma cruzi infec­tion markers
XII	Severe acute res­pi­ra­to­ry syn­drome coro­n­avirus 2 (SARS-CoV-2) infec­tion markers

The Imple­ment­ing Reg­u­la­tion will take effect on the 20^th 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 

• Update from the Euro­pean Com­mis­sion for pro­tec­tive equip­ment in the COVID-19 crisis
• Euro­pean Com­mis­sion pub­lish­es Q&A guid­ance on COVID-19 tests
• The Euro­pean Com­mis­sion pub­lish­es impor­tant guid­ance on the require­ments for COVID-19 tests under the IVDD
• New guid­ance for noti­fied bod­ies of MDD/ AIMDD lega­cy device cer­tifi­cates and IVDR class D devices