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.
Link to the Medical Device Regulation in your language
Link to the in vitro diagnostics Regulation in your language
Up to date medical device guidance documents of the European Commission (MDCG)
Link to International Organization for Standardization (ISO)
Link to European and European Electrotechnical Committee for Standardization
Link to New Approach Notified and Designated Organisations (NANDO) Information System
Link to the European Commission Expert Panels (CECP/PECP)
Fill out the form below, and a download link to the
“MDR Article 16 – What Does It Mean For Importers and Distributors of Medical Devices”
will be send to you via email.
Fill out the form below, and a download link to the
“IVD Legacy Devices”
will be send to you via email.
Fill out the form below, and a download link to the
“Medical Devices incorporating IVD Components – MDR code MDS 1014”
will be send to you via email.