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The objective of this module is to introduce you to the SIF set up by GMED to enable you to define and characterize your certification project from the 1st stage of the certification process under the European Regulation on medical devices.
DOCUMENTARY RESOURCES:
Classification rules
- Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- MDCG 2022-5: Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
- MDCG 2021-24: Guidance on classification of medical devices
- For sofware: Guide MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Designation codes
- Guide GMED : Assignation des codes visés par le Règlement d’exécution 2017/2185 dans le cadre d’une demande de certification suivant le Règlement (UE) 2017/745
- MDCG 2019-14: Explanatory note on MDR codes
CND/EMDN nomenclature
MDCG documents:
- The EMDN – The nomenclature of use in EUDAMED – January 2020
- The CND nomenclature – Background and general principles – January 2020
- MDCG 2021-12: FAQ on the European Medical Device Nomenclature (EMDN)
- MDCG 2018-2: Future EU medical device nomenclature Description of requirements
Basic UDI-DI
- MDCG 2018-1 v4: Guidance on basic UDI-DI and changes to UDI-DI
- MDCG 2019-1: MDCG guiding principles for issuing entities rules on basic UDI-DI
Sampling of devices
Application request