CEPartner4U - Downloads

Guidance documents prepared by CEpartner4U

European Directives

34 MEDDEV

Guidelines related to the European medical device Directives (source)

International harmonization in the regulation of medical devices (source)

European Association of Notified Bodies for Medical Device (source)

These documents provide guidance on specific aspects related to the activities of Notified Bodies (source)

Intended for manufacturers and users of medical devices (source)

European Commission - Interpretative documents (source)