Draft imple­ment­ing reg­u­la­tion — noti­fied body practices 

Back on Decem­ber 12, the Com­mis­sion draft­ed an Imple­ment­ing Reg­u­la­tion, which is open for con­sul­ta­tion until Jan­u­ary 23, 2026. The aim of the reg­u­la­tion is to stan­dard­ize noti­fied body prac­tices for con­for­mi­ty assess­ments under the med­ical devices and IVD med­ical devices reg­u­la­tions (MDR and IVDR). 

Among oth­ers, the draft lays out fix time­lines for dif­fer­ent con­for­mi­ty assess­ment aspects and pro­vides trans­paren­cy rules for involved costs.

The draft needs to be final­ized and then pub­lished in the Offi­cial Jour­nal of the EU in order to enter into force. The reg­u­la­tion is part of a wider ini­tia­tive of the Euro­pean Com­mis­sion to sim­pli­fy and stream­line reg­u­la­to­ry require­ments for med­ical device man­u­fac­tur­ers aim­ing to place their prod­ucts on the EU market.

The act can be accessed here.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Noti­fied bod­ies cau­tion about obsta­cles hin­der­ing their AI designation
• TEAM NB issued revi­sion 2 of IVDR best prac­tice document
• BSI first noti­fied body to offi­cial­ly pub­lish lead times under EU Med­ical Devices Regulations