+34932917739 +34915030272 - Tecno-med Ingenieros SL CIF: ES-B60945292 info@tecno-med.es

Organismos Notificados MDR 

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

Organismos Notificados IVDR 

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

 

Guias NB de MDCG relativas a los ON

Titulo

Publicación

Fecha

MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies Ocotober2019
MDCG 2019-14 Explanatory note on MDR codes December 2019
MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation December 2019
MDCG 2019-10 Application of transitional provisions concerning validity of certificates issued in accordance to the directives October 2019
MDCG 2018-8 Guidance on content of the certificates, voluntary certificate transfers November 2018
2019-5 Registration of legacy devices in EUDAMED April 2019
2019-4 Timelines for registration of device data elements in EUDAMED April 2019