EU – Unique Device Identification (UDI) System – FAQs
Published in In Vitro Diagnostic Medical Device Regulation IVDR, Medical Device Regulation MDR, Medical Device Single Audit Program - MDSAP and Unique Device Identification - UDI
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- EU – Mandate M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the CEN and the CENELEC in support of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
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- EU – COMMUNICATION FROM THE COMMISSION Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745
- EU – Mandate M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the CEN and the CENELEC in support of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
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- EU – MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
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- EU – MDR EUDAMED-UDI- Data Dictionary V5.0
- Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices
- US FDA issued the first warning letter for UDI violations to help ensure compliance
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