EUDAMED update on timelines

The Euro­pean Com­mis­sion has pub­lished new time­lines relat­ed to EUDAMED. The Com­mis­sion expects EUDAMED to be ful­ly func­tion­al in Q2 of 2023. The cor­re­spond­ing pub­li­ca­tion in the Offi­cial Jour­nal of the Euro­pean Union (OJEU) will mark the date by when dead­lines for an oblig­a­tory use of the cor­re­spond­ing mod­ules will become applicable.

6 months after the pub­li­ca­tion notice, the use of the eco­nom­ic actor, vig­i­lance, clin­i­cal investigation/ per­for­mance stud­ies and mar­ket sur­veil­lance mod­ules will become manda­to­ry. 24 months after the pub­li­ca­tion date, the UDI/ Device reg­is­tra­tion and Noti­fied Body/ Cer­tifi­cate mod­ules will become mandatory. 

We high­ly sug­gest to close­ly mon­i­tor the devel­op­ment of EUDAMED and also nation­al reg­is­tra­tions in local Euro­pean coun­tries in the inter­im. Should you have any ques­tions or con­cerns, please don’t hes­i­tate to get in touch. 

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• EUDAMED UDI/Devices and NBs/Certificates mod­ules now live
• Updat­ed EUDAMED imple­men­ta­tion dates
• MDCG guid­ance on admin­is­tra­tive prac­tices and tech­ni­cal alter­na­tives until EUDAMED full functionality
• Vol­un­tary reg­is­tra­tion with EUDAMED data­base – indus­try fears dupli­cate registrations
• New web­site on actor reg­is­tra­tion in EUDAMED 3 available
• Device Reg­is­tra­tion and Lega­cy Devices