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EU Medical Device Regulatory Affairs explained Simply

EU Medical Device Regulatory Affairs explained Simply

How to get approval to sell Medical Devices within the European Union. Understand regulatory affairs & ISO 13485 2016

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The European Union (EU) has a regulatory framework in place for medical devices to ensure the safety and effectiveness of these products. This framework is known as the EU Medical Device Regulation (MDR).

The MDR applies to all medical devices that are placed on the EU market, including devices that are imported from outside the EU. The MDR also applies to devices that are custom-made or supplied on a "made to order" basis.

The MDR requires medical device manufacturers to obtain a CE (Conformité Européene) mark for their products. The CE mark is a symbol that indicates that the device meets the MDR's safety and performance requirements. To obtain a CE mark, a manufacturer must follow the MDR's requirements for design, production, and testing of the device.

In addition to the CE mark, the MDR also requires manufacturers to follow certain rules when they are marketing their medical devices. For example, they must provide clear and accurate information about the device's intended use, risks, and benefits.

The MDR also establishes a system for monitoring and reporting adverse events and incidents involving medical devices. This helps to ensure that any problems with a medical device are identified and addressed quickly.

Overall, the EU Medical Device Regulation aims to ensure that medical devices are safe and effective for use, and that they are marketed in a responsible and transparent manner.

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