Navigation path

HIBCC UDI HRI & AIDC Formats
ICCBBA Basic UDI-DI
IFA Basic UDI-DI
IFA UDI HRI & AIDC Formats
GS1 UDI HRI & AIDC Formats
PRIVACY STATEMENT FOR MEETINGS AND EVENTS ORGANISED BY THE EUROPEAN COMMISSION
Flyer - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
EXECUTIVE SUMMARY of the Evaluation of Regulation (EC) 2679/98 on the functioning of the internal market in relation to the free movement of goods among the Member States
Designating authority's final assessment form: Key Information (EN)
Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
Application form - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) -
Procedural guidance on declaration of interests - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Declarations on confidentiality and commitment - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Manufacturer incident report Helptext 2020
MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies - August 2019
Notification of cosmetic products containing nanomaterials
MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a "person responsible for regulatory compliance" (PRRC)
Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies
Eudamed Data exchange services and entity models introductions
M2M Data Exchange Services Definition
Eudamed Data Exchange Guidelines
TSE-BSE Contact points
IVDR - UDI and device data sets to provide in EUDAMED
MDR - UDI and device data sets to provide in EUDAMED
Results per page: 5 10 15 20 25 | Page 2 out of 8

Additional tools