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Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020
state-of-play of joint assessments of Notified Bodies in the medical device sector
NCARs statistics - 2019
The CND Nomenclature - background and general principles
The European Medical Device Nomenclature (EMDN) - the nomenclature of use in EUDAMED
MDCG 2019-16 - Guidande on Cybersecurity for medical devices
MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
MDCG 2019-14 Explanatory note on MDR codes
GS1 Basic UDI-DI
HIBCC Basic UDI-DI
ICCBBA UDI HRI & AIDC Formats
HIBCC UDI HRI & AIDC Formats
ICCBBA Basic UDI-DI
IFA Basic UDI-DI
IFA UDI HRI & AIDC Formats
GS1 UDI HRI & AIDC Formats
Ongoing Guidance development within MDCG Subgroups
Flyer - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
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)
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