Perhaps you have already asked yourself which information should be entered in the EUDAMED database in the “Market Information” area.
According to our request to the European Commission, the following must be maintained:
- Exactly one country must be specified in which the medical device (UDI data set) was first placed on the market
- AND all countries where the product is currently available must be specified.
What does that mean for you now?
Point 1 is still quite simple and easy to fulfill.
Point 2, on the other hand, poses a challenge. If you already know which articles are sold in which countries, then you have already a good starting point.
However, you must ensure that this information is up-to-date until this product is not anymore available on the market. You have to take care even after you have uploaded the UDI data to the EUDAMED UDI database, you must report changes to the EU database as soon as possible.
Very few manufacturers will probably be happy with this kind of data maintenance.
As a manufacturer of medical devices, you ask yourself whether you will soon degenerate into a data manager instead of bringing new, innovative products onto the market.
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