The Medical Device Directive (MDD) is applicable to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In-vitro Diagnostic Medical Devices Directive. It describes the minimum expectations for maintaining safety and performance characteristics for medical devices in the European market. MDD is founded on the following principles:
European medical device manufacturers are expected to demonstrate compliance with all requirements listed in the Directive, Recommendations, and Implementing Regulations, in addition to the requirements in subsequent guideline documents (MEDDEVs).