What 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 (EUDAMED) referred to in Article 34(1) of Regulation (EU) 2017/745 requires
This Commission Decision confirms that four EUDAMED electronic systems (registration of economic operators, UDI/device registration, notified bodies and certificates, and market surveillance) have achieved functionality and meet the functional specifications, which starts the transition periods under MDR Article 123(3) points (d) to (ec) and IVDR Article 113(3) points (f) to (fd) as from the date of publication of this Decision.
Pillar: Medical & Healthcare · Authority: European Commission · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/eli/dec/2025/2371/oj/eng
SHA-256 integrity: 433983299d832a6a3e0a23bf61e44030d89078ee543cac79756196f2e2ea420f
Primary Citations — 8 traced to source
- 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 referred to in Article 34(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council
- the electronic system on registration of economic operators referred to in Article 30
+ 6 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/eu-eudamed-functionality-decision-2025-2371.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/eu-eudamed-functionality-decision-2025-2371.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/eu-eudamed-functionality-decision-2025-2371
- Back to registry: Browse all 10,085 compliance nodes