European Union Medical Device Regulation (EU MDR) Overview
In the modern world, the life sciences sector is going through a period of unprecedented regulatory change affecting organizations involved in pharmaceuticals, medical devices, and in-vitro diagnostics. The European Union Medical Device Regulation (EU MDR), a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensures high standards of quality and safety being produced in or supplied into Europe. By improving the safety and performance of medical devices, the EU MDR regulations are intended to improve the safety of healthcare and the performance of medical devices in Europe.
To do this, the EU MDR regulations aim to create a new and improved landscape for the quality and safety of medical devices with the following new guidelines:
- An independent assessment of all medical devices for safety and performance before they can be marketed in the EU.
- More transparent information on the benefits for patients, residual risks, and a comprehensive assessment of the overall risk/benefit ratio.
- Clear rules to enable standardization and support simpler and less complex trading between EU member states; those that do not comply will be penalized.
- New rules to support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in this sector.
- Place further responsibilities on “Notified Bodies”, an independent third party that performs conformity assessments for medium and high-risk devices.
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