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UDI requirements for medical device manufacturers in the EU

This article provides a summary of the Unique Device Identifier (UDI) requirements. UDI will be applicable to all manufacturers of medical devices in the EU. Please note, the UDI requirements in the EU are not identical to the UDI requirements of other markets, like the US market.

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Medical Device Regulation codes

Learn more about Medical Device Regulation (MDR) codes, as well as the EMDN codes which are the device-related codes needed under the MDR. They are also related to the notified bodies for class IIb devices, and manufacturers need to be aware of them because they are used when reporting to EUDAMED for all classes of devices.

What is MDR

What is a medical device according to the MDR

It is important to know if a product is a medical device because this is what determines if the MDR applies to that product or not. Therefore, it has a major impact on how the device realisation is done as well as how the product should be approved for the European market.

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What is new in the 2017/745 MDR?

The new Medical Device Regulation applies to all legal manufacturers of medical devices, as well as importers and distributors of medical devices that are to be sold on the EU market. The European Commission describes the new MDR as

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