Navigation path

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
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
SUE Reporting Guidelines
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
Guidance on Content of the certificates, voluntary certificate transfers
MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI
Commission reply to a Petition "For a Compensation Fund for PIP Breast Implants and CE" from the website
New Manufacturer Incident Report
New Manufacturer Incident Report helptext
MDR and IVDR implementing measures rolling plan
Résultats par page: 5 10 15 20 25 | Page 1 sur 6

Additional tools

Restez connnecté