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Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
IMDRF Standards Checklist modified in scope of COVID-19
State of play of joint assessments of Notified Bodies in the medical device sector
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
MDCG 2019-8 v2 - 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 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)
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 - Guidance 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
Flyer - 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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