“Market Information”: Meaning and Integration in EUDAMED
The implementation of Unique Device Identification (UDI) means that medical device manufacturers are obliged to provide health authorities such as the FDA or EUDAMED with a comprehensive range of product information. The so-called “market information” is an integral part of these UDI regulations for medical devices.
This information is crucial for the Unique Device Identification (UDI) system according to the EUDAMED regulation. In the market information, the manufacturer must list all countries in which the product will be available. This is particularly crucial with regard to documentation and patient safety, as it enables improved transparency and traceability.
Guideline for filling in the “Market Information” in EUDAMED
When filling out the Market Infor in EUDAMED, the following points should be noted:
- A country must be specified as “Originally placed on the market”, i.e. the country in which the medical device (UDI record) was first placed on the market.
- All countries in which the product is currently available, or will be available at a specific time, must be specified.
- In principle, there should be a contractual agreement between the manufacturer and a distribution partner.
Example :
We have prepared a video that shows you exactly how to add Market information to our EUDAMED Add-On :
We have prepared a second video that shows you exactly how to add Market information in the EUDAMED Playground :
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