A major milestone for the European medical device industry is approaching.
Following the publication of Commission Decision (EU) 2025/2371 on the 27th of November 2025, the mandatory use of the first modules of the European Database on Medical Devices (EUDAMED) will start on 28 May 2026 after the currently ongoing six-month transition period.
From that date, economic operators under (EU) 2017/745 Medical Device Regulation, MDR and (EU) 2017/746 In-Vitro Diagnostics Regulation, IVDR must use the following four EUDAMED modules:
- Actor Registration – registration of economic operators and obtaining the SRN
- UDI / Devices Registration – registration of devices and UDI data
- Notified Bodies & Certificates – certificate information linked to devices
- Market Surveillance – coordination of market surveillance activities between authorities.
Are you curious where your organization stands towards this transition?
We can take the pressure off your team. Whether you are just starting preparations or already working on your EUDAMED data population, we are happy to support, now or when the deadline gets closer.
Starodub provides manufacturers with End-to-end EUDAMED registration support and ongoing regulatory guidance for the modules under their responsibility: Actor Registration and UDI / Devices Registration.
Contact us at info@starodub.nl to secure your smooth transition and meet the 28 May 2026 deadline with confidence.
