EUDAMED mandatory use: What manufacturers need to know
What is EUDAMED and why does it matter?
EUDAMED is the European Database on Medical Devices. It is the central IT system used by the European Commission, Competent Authorities, manufacturers, and Notified Bodies to share regulatory information under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
EUDAMED has been introduced in phases. Each module only becomes legally mandatory after the European Commission formally declares it functional in the Official Journal of the European Union (OJEU).
On 27 November 2025, the Commission published Commission Decision (EU) 2025/2371, confirming that four EUDAMED modules are fully functional. This publication starts the legal countdown to mandatory use.
Which EUDAMED modules are now mandatory?
The following four modules are covered by the Commission Decision and move to mandatory use:
- Actor Registration – registration of economic operators (e.g. manufacturers, authorized representatives, importers)
- UDI & Device Registration – registration of devices and their Unique Device Identifiers (UDIs)
- Notified Bodies & Certificates – electronic information on certificates and related decisions
- Market Surveillance – support for Competent Authority surveillance activities
These modules link directly to existing obligations in MDR and IVDR; EUDAMED is now the required tool to fulfil them.
Key legal dates – at a glance
All dates below are legally triggered by the OJEU publication on 27 November 2025.
- 27 November 2025: Commission Decision (EU) 2025/2371 published, which acts as the formal notice that the four EUDAMED modules are functional
- 28 May 2026 – Use of the four modules, actor registration, UDI & Device registration, Notified Bodies & certificates and market surveillance becomes mandatory.
- 28 November 2026 – The final deadline to complete EUDAMED registration of legacy devices (devices placed on the market before 28 May 2026 but still sold afterwards)
- 28 May 2027 – Notified Bodies must complete upload of relevant legacy certificate information (18‑month period)
What does “mandatory use” mean in practice?
From 28 May 2026, EUDAMED is no longer optional or “voluntary”. If an obligation is linked to one of the four modules, it must be done in EUDAMED. Parallel national systems or alternative processes are no longer sufficient.
Manufacturer obligations from 28 May 2026 (new devices)
- Actor registration (before you place devices on the EU market: All economic operators including EU representatives must be registered in the Actor module. Registration results in an Actor ID / Single Registration Number (SRN). Non‑EU manufacturers register via their EU Authorized Representative. The relevant Competent Authority validates the registration and issues the Single Registration Number (SRN). Without a valid SRN you cannot legally place devices on the EU market.
- Device registration (before first placement). For new devices placed on the EU market from 28 May 2026: Devices, systems, and procedure packs must be registered in the UDI & Device module before first placement. Manufacturers must register basic UDI-DI, all relevant UDI-DI(s) and device attributes (risk class, intended purpose etc) before the Notified Body can link the certificates to those devices.
If the device is not in EUDAMED, it should not be placed on the market.
Data consistency is critical
All EUDAMED data must match including technical documentation, labelling and Instructions for use (IFU) and certificates issued by the Notified Body. Inconsistencies can delay certification, surveillance actions, or authority communications.
Legacy devices: Special transition rules
Legacy devices that were placed on the EU market before 28 May 2026, and will continue to be placed on the market after that date
For these devices:
- Registration in EUDAMED must be completed by 28 November 2026
- A practical approach is recommended:
- Triage your portfolio (MDR/IVDR devices vs legacy devices)
- Map existing UDI‑Dis
- Prepare structured or bulk upload data
In some cases, if an equivalent MDR/IVDR device is already registered, legacy registration may not be required for that device family (portfolio logic must be justified).
Notified Bodies and certificate visibility
From 28 May 2026 Notified Bodies enter certificate and decision information into the NB & Certificates module. Some device information only becomes publicly visible after the certificate data is uploaded. It’s important to remember that your Notified Body can only register certificates once:
- Actors (including EU representative) are registered
- Devices and/or Basic UDI‑DI are registered
- Early alignment on certificate identifiers, scope text, and timing is essential.
Market surveillance: What to expect
Competent Authorities use the Market Surveillance module to support surveillance activities. Accurate actor roles, contact points, and device registrations help avoid delays or missed communications. The Commission indicates that Vigilance and Post‑Market Surveillance functionality is expected later (Q3 2026), while some modules remain under development.
How we’re supporting our customers
DNV is implementing measures to meet the 28 May 2026 mandatory-use deadline and ensure timely submission of required application and certificate information to EUDAMED. Until that date, certificate registration by Notified Bodies is not mandatory.
To help manufacturers prepare, we have developed a Readiness checklist outlining the key steps organizations should take to ensure they are ready for mandatory use and remain compliant. The checklist is freely available to download and provides a practical way for manufacturers to assess their readiness and plan the actions needed ahead of the deadline.
3/10/2026 2:06:00 PM
