EUROPEAN COMMUNITY – MDR Guidelines
Implementation of Medical Devices EU-Regulation – Focus on Manufacturers’ obligations
Implementation Model for Medical Devices Regulation Step by Step Guide
Fact Sheet for Manufacturers of Medical Devices
Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide
Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices
NOTIFIED BODIES GUIDELINES
BSI – General Safety and Performance Requirements (Annex I) in the New Medical Device Regulation
BSI – MDR Classification Rules
