New EU Reg­u­la­tion on noti­fied body con­for­mi­ty assess­ments published

The Euro­pean Com­mis­sion has pub­lished Com­mis­sion Imple­ment­ing Reg­u­la­tion (EU) 2026/977, intro­duc­ing uni­form qual­i­ty man­age­ment and pro­ce­dur­al require­ments for con­for­mi­ty assess­ment activ­i­ties car­ried out by noti­fied bod­ies under Reg­u­la­tions (EU) 2017/745 and 2017/746 (MDR and IVDR).

The reg­u­la­tion address­es long-stand­ing indus­try pain points: incon­sis­tent quo­ta­tion prac­tices, unpre­dictable time­lines, and vari­able re-cer­ti­fi­ca­tion approach­es across noti­fied bod­ies. It estab­lish­es max­i­mum time­frames for key assess­ment phas­es and requires noti­fied bod­ies to pub­lish annu­al per­for­mance reports from Jan­u­ary 1, 2028.

More specif­i­cal­ly:

• Arti­cle 1 lays out details that needs to be pro­vid­ed by man­u­fac­tur­ers so that noti­fied bod­ies can issue a quo­ta­tion. For the quo­ta­tion itself, the noti­fied body is required to pro­vide esti­mat­ed over­all and poten­tial extra costs;
• Arti­cle 2 is on time­lines. Max­i­mum time­lines are 30 days for the appli­ca­tion review, 120 days for qual­i­ty man­age­ment sys­tem audit activ­i­ties, 90 days for prod­uct ver­i­fi­ca­tion and 20 days for deci­sion and cer­ti­fi­ca­tion. For qual­i­ty man­age­ment and prod­uct ver­i­fi­ca­tion audit activ­i­ties, the clock starts tick­ing after the sig­na­ture of the cor­re­spond­ing contract;
• Arti­cle 3 clar­i­fies the num­ber of allowed inter­rup­tions of the afore­men­tioned time­lines, e.g. due to non-com­pli­ances. For exam­ple, qual­i­ty man­age­ment sys­tems audit activ­i­ties may be inter­rupt­ed up to four times;
• Arti­cle 4 oblig­es noti­fied bod­ies to imple­ment mea­sures to mon­i­tor the dura­tion of con­for­mi­ty assess­ment activ­i­ties and relat­ed costs – both shall be pub­lished in an annu­al report;
• In the fur­ther course, the reg­u­la­tion lays out require­ments for the re-cer­ti­fi­ca­tion of prod­uct and qual­i­ty man­age­ment sys­tem cer­tifi­cates as well as on the deci­sion on re-certification.

For those who already read the draft from last Decem­ber, it should be not­ed that the con­tents and struc­ture were large­ly maintained. 

The reg­u­la­tion enters into force on 25 Feb­ru­ary 2027.

The full text avail­able here. 

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Draft imple­ment­ing reg­u­la­tion — noti­fied body practices 
• MDR extend­ed tran­si­tion peri­od and noti­fied body agree­ment