UDI, ¿que es?
UDI en etiqueta producto, ¿como esta compuesto?
UDI en EUDAMED, ¿Qué es el UDI-DI BASICO?
UDI plazos
Formación ONLINE UDI
Documentos MDCG UDI – EUDAMED
Title | Publication | Date |
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 | February 2019 |
MDCG 2019-1 | MDCG guiding principles for issuing entities rules on basic UDI-DI | January 2019 |
MDCG 2018-7 | Provisional considerations regarding language issues associated with the UDI database | October 2018 |
MDCG 2018-6 | Clarifications of UDI related responsibilities in relation to article 16 | October 2018 |
MDCG 2018-5 | UDI assignment to medical device software | October 2018 |
MDCG 2018-4 | Definitions/descriptions and formats of the UDI core elements for systems or procedure packs | October 2018 |
MDCG 2018-3 | Guidance on UDI for systems and procedure packs | October 2018 |
MDCG 2018-2 | Future EU medical device nomenclature – Description of requirements | March 2018 |
MDCG 2018-1 v2 | Guidance on basic UDI-DI and changes to UDI-DI | February 2019 |
2019-5 | Registration of legacy devices in EUDAMED | April 2019 |
2019-4 | Timelines for registration of device data elements in EUDAMED | April 2019 |