What is EU MDR?

The European Union (EU) Medical Devices Regulation (MDR) establishes a regulatory framework for medical devices that safeguards public health and safety while supporting the competitiveness of the market.

The Regulation will come into force officially in 2020, and will place restrictions and reporting requirements on substances used in the design and manufacturing process of medical devices, excluding IV medical devices, in order to reduce the potential risks posed by some 2,000 substances.

The EU MDR covers devices, parts of those devices, or materials used within those devices that are invasive and come into contact with the body; that administer or re-administer medicines, bodily fluids or other substances; and that are used to transport or store any such liquid.

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