About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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:

  • The Essential Requirements – Annex I - which outlines the necessary requirements and precautions to be considered in the design, use, and disposal of devices.
  • Classification of devices and conformity assessment procedure based on the level of risk inherent to the device.
  • Control of production to ensure conformity to type.
  • Monitoring and vigilance.

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).  

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