DGM - Rules - MDD - Product Requirements

Rules - MDD

Product Requirements

In the Directive the main requirements for the medical devices are described in general terms.

The essential requirements for the products can, however, be divided into six general requirements and a large number of more specific requirements:

The general requirements:

High level of safety
Inherently safe design and construction
Suitability
Performance stability
Transport safety
Weighing of risks against benefits

The specific requirements:

Safe materials
Compatibility between materials used and biological tissues, cells and body fluids
Sterilization safety
Mechanical safety
Electromagnetic compatibility
Fire and explosion resistance
Accuracy and stability
Radiation protection
Alarm function
Electrical safety
Labeling requirements
Requirements for instructions

To assist individual manufacturers special harmonized standards that offer interpretations of acceptable levels to fulfill the "Essential Requirements" have been prepared.

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