通用法规：

MEDICAL DEVICE REGULATION EU 2017/745

相关指南文件：

UDIWG 2018-1: UDI Database, Definitions/Descriptions and formats of the UDI core elements

MDCG-2018-2: Future EU medical device nomenclature - Description of requirements

MDCG-2018-3: Guidance on UDI for systems and procedure packs

MDCG-2018-4: Definitions/descriptions and formats of the UDI core elements for systems or procedure packs

MDCG-2018-5: UDI assignment to medical device software

MDCG-2018-6: Clarifications of UDI related responsibilities in relation to article 16

MDCG-2018-7: Provisional considerations regarding language issues associated with the UDI database

MDCG-2019-1: MDCG guiding principles for issuing entities rules on basic UDI-DI

MDCG-2019-2: Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017

MDCG-2018-1V4: Guidance on basic UDI-DI and changes to UDI-DI

MDCG-2019-4: Timelines for registration of device data elements in EUDAMED

MDCG-2019-5: Registration of legacy devices in EUDAMED

Commission Implementing Decision (EU) 2019/939: Designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices

MDCG 2020-18:MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers

MDCG 2021-09:MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers

MDCG 2021-19:Guidance note integration of the UDI within an organisation’s quality management system

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