The EUDAMED first four mod­ules will be manda­to­ry to use as from 28 May 2026

The Com­mis­sion Deci­sion (EU) 2025/2371 of 26 Novem­ber 2025 on the notice regard­ing the func­tion­al­i­ty and the ful­fil­ment of the func­tion­al spec­i­fi­ca­tions of cer­tain elec­tron­ic sys­tems includ­ed in the Euro­pean Data­base on Med­ical Devices declar­ing the func­tion­al­i­ty of the first four mod­ules has been pub­lished in the Offi­cial Jour­nal of the EU of 27 Novem­ber 2025.

In accor­dance with the tran­si­tion­al pro­vi­sions set out in Reg­u­la­tion (EU) 2024/1860, this pub­li­ca­tion trig­gers a tran­si­tion peri­od of 6 months for the manda­to­ry use of EUDAMED.

There­fore, as from 28 May 2026 the fol­low­ing EUDAMED mod­ules will become oblig­a­tory: 

• Actor reg­is­tra­tion
• UDI/Devices reg­is­tra­tion
• Noti­fied Bod­ies & Certificates
• Mar­ket Surveillance

Vig­i­lance (VGL) and Clin­i­cal Inves­ti­ga­tion mod­ules will fol­low later.

Please note that in order for an eco­nom­ic oper­a­tor to pro­vide data to EUDAMED, the cor­re­spond­ing par­ty needs to be reg­is­tered with the cor­re­spond­ing role in EUDAMED. As such, obtain­ing a sin­gle reg­is­tra­tion num­ber (SRN), should always be the first step. 

For a bet­ter overview, we have pre­pared a quick overview and answers to some FAQs:

Date	Event/Deadline	Affect­ed Modules/Content	Notes
28 May 2026	Manda­to­ry use begins (end of transition)	Actor reg­is­tra­tion, UDI/Device Reg­is­tra­tion, Noti­fied Bod­ies & Cer­tifi­cates, Mar­ket Surveillance	With­out actor & UDI reg­is­tra­tion, mar­ket access is not pos­si­ble for cer­tain devices
28 May 2026	Reg­is­tra­tion oblig­a­tion for eco­nom­ic operators	Actor reg­is­tra­tion	Actors need to reg­is­ter them­selves and obtain a SRN in order to reg­is­ter devices in EUDAMED
28 May 2026	Reg­is­tra­tion oblig­a­tion for cer­tain reg­u­la­tion and lega­cy devices	UDI/Device Mod­ule	Applies if the first plac­ing on the mar­ket occurs on or after May 28, 2026; EUDAMED reg­is­tra­tion must be done before devices are placed on the market
28 Nov 2026	End of grace peri­od for the reg­is­tra­tion of cer­tain reg­u­la­tion and lega­cy devices	UDI/Device Mod­ule	Applies if the first plac­ing on the mar­ket occurred before May 28, 2026 and con­tin­ues beyond that date
TBA	Roll-out of addi­tion­al modules	Vig­i­lance (VGL), Clin­i­cal Investigations	Tim­ing depends on com­mis­sion con­fir­ma­tion of functionality

Do I need to be reg­is­tered with EUDAMED in order to reg­is­ter my products?

Yes, before prod­ucts can be reg­is­tered, the com­pa­ny must be reg­is­tered and assigned an SRN.

My com­pa­ny is reg­is­tered with EUDAMED, but I can­not reg­is­ter any prod­ucts. Why is that?

To reg­is­ter prod­ucts, at least two actors are required: a “pro­pos­er” and a “con­firmer”. These roles can be assigned by the “local actor admin­is­tra­tor” (LAA). The LAA can also take on one of these two roles, but not both. This means that at least one addi­tion­al actor is required who must be linked to the com­pa­ny profile.

Do lega­cy devices also need to be registered?

Yes, as soon as prod­uct reg­is­tra­tion becomes manda­to­ry across the board, this oblig­a­tion will also apply to lega­cy devices. Please see table above for fur­ther details. Once the trans­fer of a lega­cy device to MDR/IVDR has been com­plet­ed, these prod­ucts must be re-reg­is­tered as nor­mal and linked to the lega­cy device registration. 

Are there any prod­ucts that do not need to be reg­is­tered? And which are they?

Lega­cy and Reg­u­la­tion devices

• Do not need to be reg­is­tered if indi­vid­ual sales units are no longer placed on the mar­ket when the UDI/DEV mod­ule becomes manda­to­ry, unless a PMSV action occurs.
• Lega­cy devices do not need to be reg­is­tered if “the same device” is already reg­is­tered as a Reg­u­la­tion device.

Def­i­n­i­tion of “the same device”

• Same iden­ti­fi­ca­tion (e.g., UDI-DI, catalogue/reference num­ber, trade name).
• Excep­tion: if changes to the Reg­u­la­tion device result in a new UDI-DI, it is not con­sid­ered “the same device.”

Old devices (MDCG 2021-25 Rev. 1 and MDCG 2022-8)

• Can­not be reg­is­tered in the UDI/DEV module.
• If sub­ject to a seri­ous inci­dent report (MIR) or field safe­ty cor­rec­tive action (FSCA), the man­u­fac­tur­er must pro­vide a lim­it­ed device dataset in the VGL module.

Cus­tom-made devices

• Can­not be reg­is­tered in the UDI/DEV module.
• If sub­ject to a MIR or FSCA, the man­u­fac­tur­er must pro­vide a lim­it­ed device dataset in the VGL module.

When can I start reg­is­ter­ing devices?

The UDI/Device mod­ule has been avail­able for vol­un­tary use since Octo­ber 2021.

What about the Vig­i­lance Module?

The VGL mod­ule is not yet avail­able for vol­un­tary use. It will be released when it becomes mandatory.

Please note that we have not specif­i­cal­ly regard­ed sys­tems and pro­ce­dure packs in our con­sid­er­a­tions. Should you have spe­cif­ic requests in that regard, please let us know.

For more infor­ma­tion, please see the Commission’s Q&A on the Grad­ual Roll-Out of EUDAMED.

In addi­tion, we would like to take this oppor­tu­ni­ty to high­light the excel­lent EUDAMED help and sup­port sec­tion. Please feel free to get in touch should you have any questions.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• EUDAMED Work­shop – Prepar­ing for Compliance
• Q&A doc­u­ment on the grad­ual roll­out of EUDAMED available
• Euro­pean Med­ical Devices Nomen­cla­ture (EMDN) helpdesk is live!