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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
GROW/E3 - Hackathon Bucharest - challenge - 18-19 May 2019
Status of translation and publication of UNECE Regulations in the area of vehicle approval
European Construction Sector Observatory - Policy fact sheet - Czech Republic - Amendment to the Building Act
MDCG 2019-5 Registration of legacy devices in EUDAMED
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
SUE Reporting Guidelines
Regulation (EU) 2016/425 on personal protective equipment (PPE): Transition from Directive 89/686/EEC – Products in the stocks of the manufacturer before 21 April 2019
Regulation (EU) 2016/425 on personal protective equipment: Validity of an EC type-examination certificate and revision of harmonised standards
MDCG 2019-3 Interpretation of Article 54(2)b
Commission Delegated Regulation establishing a Common Training Test for ski instructors under Article 49b of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of the professional qualifications
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
MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES.
MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI
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