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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
MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI
Factsheet for the Procurement Ecosystem of Medical Devices and in vitro Diagnostic Medical Devices
Factsheet for Authorities in non-EU/EEA States on Medical Devices and in vitro Diagnostic Medical Devices
Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical Devices
NCARs statistics - 2018
Commission reply to a Petition "For a Compensation Fund for PIP Breast Implants and CE" from the website change.org
New Manufacturer Incident Report
New Manufacturer Incident Report helptext
Applicant's undertakings form for call for applications in the view of the designation of UDI issuing entities
MDR and IVDR implementing measures rolling plan
Factsheet for Manufacturers of Medical Devices - AR, JP, RU
Factsheet for Manufacturers of Medical Devices
Implementation Model for Medical Devices Regulation - Step by Step Guide
Factsheet for Manufacturers of in vitro Diagnostic Medical Devices
Implementation Model for in vitro Diagnostic Medical Devices Regulation - Step by Step Guide
MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES
MDCG Working Group 1: Notified Bodies Oversight (NBO) - Terms of reference
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