INFORMATION

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

Expert Panel Publications
Link to the European Commission Expert Panel guides for manufacturors