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Eudamed Guidance documents - Alysidia

EUDAMED is the European Database on medical devices. Its purpose is to strengthen market surveillance and transparency in medical device field providing to competent national authorities with quick access to information. EUDAMED also contribute to the uniform application of the Directives.

Here are some link to better understand UDI and EUDAMED

Document Short summary Author
a3-ready_for_udi-bd GS1 quick UDI
budi_mdr_en MDR UDI attributes EU
GS1_Healthcare_GTIN GTIN allocation
gs1_udi_guide_final_20170324 Guide on Unique Device Identification (UDI)
implementation in the USA and in the EU
imdrf-cons-udi-system-n48-180712 Unique Device Identification system (UDI system) Application Guid IMDRF
md_nomenclature_en Medical Devices Nomenclature EU
mdcg_2018_2_nomenclature_en Medical device nomenclature
Description of requirements
MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers MDCG
MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs MDCG
MDCG 2018-1 v3 Guidance on basic UDI-DI and changes to UDI-DI MDCG
MDCG 2019-1 MDCG guiding principles for issuing entities rules on basic UDI-DI MDCG
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
MDCG 2018-4 Definitions/descriptions and formats of the UDI core elements for systems or procedure packs MDCG
MDCG 2018-5 UDI assignment to medical device software MDCG
MDCG 2018-6 Clarifications of UDI related responsibilities in relation to article 16 MDCG
MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database MDCG

Alysidia is providing tools and resources to deal with EUDAMED and UDI. And the amazing news here is that all this is offered within a single roof. Should you have any more questions, Alysidia will be happy to assist you

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