Update (2020-04-23): due to the COVID-19 pandemic, the EU MDR date of application was postponed by 1 year, from 26 May 2020 to 26 May 2021. The possibility for EU-wide derogations for certain critically-needed devices has also been codified. For more information, see Regulation (EU) 2020/561 (link).
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 came into force officially in 2021, and places restrictions and reporting requirements on substances used in the design and manufacturing process of medical devices, excluding in vitro (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.
- EU MDR Declaration Acceptance Criteria