Q&A doc­u­ment on the grad­ual roll­out of EUDAMED available

On Novem­ber 21, The Euro­pean Com­mis­sion issued a Q&A doc­u­ment on the grad­ual roll­out and use of EUDAMED.

The doc­u­ment fol­lows amend­ing Reg­u­la­tion (EU) 2024/ 1860, which opens the pos­si­bil­i­ty to oblige man­u­fac­tur­ers and oth­er eco­nom­ic oper­a­tors to use cer­tain EUDAMED modules.

Impor­tant ques­tions include, but are not lim­it­ed to:

• What are the impli­ca­tions of the amend­ment to Arti­cle 34 MDR, enabling the grad­ual roll-out of Eudamed? 
• When will the use of the ACTOR (ACT) mod­ule become mandatory? 
• When will the use of the UDI/DEV mod­ule become mandatory?
• When will the use of the Post-Mar­ket Sur­veil­lance and Vig­i­lance (VGL) mod­ule become mandatory?

This means that all oblig­a­tions linked to a cer­tain mod­ule will become manda­to­ry, six months after this par­tic­u­lar mod­ule is pub­lished in the Offi­cial Jour­nal of the Euro­pean Union. 

Key changes include that arti­cle 120(8) of the MDR and arti­cle 110(8) of the IVDR are delet­ed by the amend­ment, and Arti­cle 123(3)(d) of the MDR and arti­cle 113(3)(e) of the IVDR are rephrased. This means that all oblig­a­tions linked to a cer­tain mod­ule will become manda­to­ry, six months after this par­tic­u­lar mod­ule is pub­lished in the Offi­cial Jour­nal of the Euro­pean Union. 

Please fol­low us and stay up to date on fur­ther insights and changes.

Any addi­tion­al ques­tions? Please get in touch with us.

The doc­u­ment can be accessed in the library sec­tion of our website. 

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Effi­cient sup­port for med­ical device man­u­fac­tur­ers: mdi Europa and the EUDAMED database
• Exten­sion of IVDR tran­si­tion peri­ods and ear­ly launch of Eudamed takes last hurdle
• Reg­is­ter­ing a lega­cy device in Eudamed is a good step
• Euro­pean Com­mis­sion EUDAMED web­site expanded