New EUDAMED Registration Requirements: The Countdown Begins
EUDAMED is the European database for medical devices and in vitro diagnostics. It serves as a central platform for collecting, exchanging, and providing essential information, thereby strengthening safety, transparency, and collaboration between manufacturers, authorities, and other stakeholders.
With the publication of Commission Decision (EU) 2025/2371 in the Official Journal, the European Commission has confirmed that four EUDAMED modules have successfully passed their audits and meet the defined functional specifications. These modules include:
- Actor registration
- UDI / Devices registration
- Notified Bodies & Certificates
- Market Surveillance
The transition period triggered by the publication in the Official Journal will end on May 28, 2026, when the use of these modules will be mandatory.
What does this mean for medical device manufacturers?
1. Product registration in EUDAMED applies with the following transition periods:
- 6 months for products first placed on the market on or after the publication date in the Official Journal
- 12 months for products first placed on the market before the publication date
After these deadlines, products must be registered before they are placed on the market for the first time.
2. Special provisions apply to legacy devices. Registration is not required if:
- the product will no longer be placed on the market after the publication of the UDI module (except for vigilance or field safety corrective action cases)
- the product is already registered as a regulation device (same UDI, REF, or trade name)
- the product was placed or put into service on the market before 21 May 2021
In all other cases, the 12-month transition period applies.
3. Custom-made devices are exempt from the registration requirement.
Strategic relevance for manufacturers and economic operators
With the mandatory use of the first EUDAMED modules starting in May 2026, the EU is pursuing clear objectives:
- EU-wide one-stop shop for device and certificate registration
- Unified Single Registration Number (SRN)
- Reduced administrative burden
- Increased transparency
- Better traceability of medical devices
- Strengthened market surveillance
WQS supports medical device manufacturers in structured EUDAMED implementation, data preparation, and MDR-compliant registration, including:
- Assessment of all products with regard to transition periods
- Establishment or optimisation of UDI and data management processes
- Ensuring complete and consistent EUDAMED master data
- Resource and process planning for mandatory use starting 28 May 2026
Contact us: us.wqs.de
