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 guidance |
GS1 |
| budi_mdr_en | MDR UDI attributes | EU Community |
| GS1_Healthcare_GTIN | GTIN allocation rules |
GS1 |
| gs1_udi_guide_final_20170324 | Guide on Unique Device Identification (UDI) implementation in the USA and in the EU |
GS1 |
| imdrf-cons-udi-system-n48-180712 | Unique Device Identification system (UDI system) Application Guid | IMDRF |
| md_nomenclature_en | Medical Devices Nomenclature | EU Community |
| mdcg_2018_2_nomenclature_en | Medical device nomenclature Description of requirements |
EU Community |
| 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.
