KNOWLEDGE BASE

Basic Medical Device Knowledge Source

Provides you with access to the most relevant documents, guidances and white papers relevant to your daily work in the area of medical devices and in vitro diagnostic medical devices

Regulation (EU) 2017/745 (MDR)

Link to the Medical Device Regulation in your language

Regulation (EU) 2017/746 (IVDR)

Link to the in vitro diagnostics Regulation in your language

MDCG

Up to date medical device guidance documents of the European Commission (MDCG)

ISO

Link to International Organization for Standardization (ISO)

CEN/CENELEC

Link to European and European Electrotechnical Committee for Standardization

NANDO

Link to New Approach Notified and Designated Organisations (NANDO) Information System

European Commission Expert Panels

Link to the European Commission Expert Panels (CECP/PECP)

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