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Designating authority's final assessment form: Key Information (EN)
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
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
DSVG 03 - Cardiac Implantable Electronic Devices (CIED) - Guidance on the vigilance system for CE-marked medical devices
DSVG 04 - Breast Implants - Guidance on the vigilance system for CE-marked medical devices
MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies - August 2019
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 v2 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
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
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