On its web­site on the Euro­pean data­base on med­ical devices (EUDAMED), the Euro­pean Com­mis­sion has declared a new timetable for the new Eudamed med­ical device database. 

Accord­ing to the Com­mis­sion, some of the mod­ules for the new Eudamed 3 data­base will be in oper­a­tion about the same time as Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) ful­ly applies on 26 May 2021. 

It is planned that:

  1. the ‘actor’ reg­is­tra­tion mod­ules will be avail­able by March 2021, 
  2. the mod­ule on UDI and device reg­is­tra­tion will become avail­able once they are oper­at­ing, prob­a­bly by May 2021 and
  3. the Noti­fied Body cer­tifi­cates mod­ule will also be avail­able by May 2021.

The Com­mis­sion has also declared that it is intend­ing to pub­lish a posi­tion paper on the use of the actor reg­is­tra­tion mod­ule and on the issu­ing of the Sin­gle Reg­is­tra­tion Num­ber (SRN), a cru­cial tool, by the end of June this year.

There is cur­rent­ly no infor­ma­tion avail­able by when the remain­ing mod­ules on vig­i­lance, mar­ket sur­veil­lance and clin­i­cal inves­ti­ga­tions will be ready. But the Com­mis­sion declared that it still plans for Eudamed 3 to become ful­ly func­tion­al in 2022.

Sources: Euro­pean Com­mis­sion web­site, Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on this website