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Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
European Commission expert panels on medical devices and in vitro diagnostic devices
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 Questions and answers: Requirements relating to notified bodies
Factsheet for healthcare professionals and health institutions
Eudamed Data exchange services and entity models introductions
M2M Data Exchange Services Definition
Eudamed Data Exchange Guidelines
MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI
TSE-BSE Contact points
IVDR - UDI and device data sets to provide in EUDAMED
MDR - UDI and device data sets to provide in EUDAMED
EUDAMED UDI Device Data Dictionary
MDCG 2019-5 Registration of legacy devices in EUDAMED
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
MDCG 2019-3 Interpretation of Article 54(2)b
Eudamed Functional Specifications
Medical Devices Nomenclature
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
Meetings of MDCG and subgroups – 2019
Guidance on Content of the certificates, voluntary certificate transfers
Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices
MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES.
Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) - infographics
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