The Euro­pean com­mis­sion has recent­ly announced that Eudamed will not be ful­ly oper­a­tional until the sec­ond quar­ter of 2024. Under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR), a guid­ance doc­u­ment was pub­lished in 2021 to pro­vide rec­om­mend­ed actions to eco­nom­ic oper­a­tors until Eudamed is ful­ly work­ing. A sim­i­lar doc­u­ment, MDCG 2022-12 Guid­ance on har­monised admin­is­tra­tive prac­tices and alter­na­tive tech­ni­cal solu­tions until Eudamed is ful­ly oper­a­tional, was now issued for Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR). 

The doc­u­ment, includes a 30-page table sug­gest­ing alter­nate res­o­lu­tions to the cor­re­spond­ing IVDR require­ments relat­ed to Eudamed. 

As a rule of thumb, com­pa­nies should abide by the cor­re­spond­ing require­ments under the med­ical devices direc­tives, name­ly the IVD Direc­tive (IVDD), the Med­ical Devices Direc­tive (MDD) and Active Implantable Med­ical Device Direc­tive (AIMDD) until Eudamed is ready for use and com­pul­so­ry. For exam­ple, com­pa­nies should report to com­pe­tent author­i­ties in the involved mem­ber states for vig­i­lance pur­pos­es, clin­i­cal inves­ti­ga­tion appli­ca­tions and reg­is­ter­ing devices, and as eco­nom­ic oper­a­tors if they are not choos­ing vol­un­tary sub­mis­sion under Eudamed beforehand. 

Eudamed con­tains six dif­fer­ent modules:

  1. Actor reg­is­tra­tion;
  2. noti­fied bod­ies and certificates;
  3. vig­i­lance;
  4. clin­i­cal inves­ti­ga­tion and per­for­mance studies;
  5. mar­ket surveillance;
  6. and Unique Device Iden­ti­fi­ca­tion (UDI) and device registration. 

Three mod­ules are already in oper­a­tion on a vol­un­tary basis:

  1. Actor reg­is­tra­tion;
  2. noti­fied bod­ies and certificates;
  3. and UDI and device registration. 

When the entire sys­tem is oper­a­tional, with all six mod­ules work­ing, there are two impor­tant dead­lines. The first will be six months after the pub­li­ca­tion of the notice in the Offi­cial Jour­nal of the Euro­pean Union, i.e. the fourth quar­ter of 2024. This date will mark the point where the Eudamed require­ments will become com­pul­so­ry for the actor reg­is­tra­tion, vig­i­lance, clin­i­cal inves­ti­ga­tion and per­for­mance stud­ies and mar­ket sur­veil­lance mod­ules. The sec­ond dead­line is 24 months after the afore­men­tioned notice, i.e. the sec­ond quar­ter of 2026 when Eudamed will become com­pul­so­ry for UDI/device reg­is­tra­tion and noti­fied bod­ies and cer­tifi­cates. 

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

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website