MDR Art. 29 et 31
Registration of devices and economic operators in EUDAMED
Assignment of the Basic UDI-DI and registration of the manufacturer, authorised representative and importer in EUDAMED
- Category
- Founding texts
- Market
- European Union
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
- Applicable since
- May 28, 2026
In practice
Registration has been mandatory since 28 May 2026. The manufacturer first obtains a single registration number (SRN), then registers each device with its Basic UDI-DI. Economic operator data must be updated within one week (Article 31(4)), the UDI database within 30 days for a change not requiring a new UDI-DI (Annex VI, Part C, Section 5.10), and accuracy confirmed no later than one year after registration and every two years thereafter (Article 31(5)).
Official sources
https://eur-lex.europa.eu/eli/reg/2017/745/oj/fraSee where this text lands in your roadmap
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