As already mentioned, the new EUDAMED will become the EU database which will contain information about
- type of devices on the EU market (UDI-DI)
- Economic Operators (manufacturer, EU representative, importer)
- Certificates
- Vigilance reporting
- Application to initiate clinical trials
- Market surveillance (authority use)
Some of this information will be publicly available.
But despite this database becoming active some time from now, it will still not offer the feature to provide the specific classification of a specific device. To identify the classification, one has to apply the classification rules (per MDD, Annex IX, or in the future MDR, Annex VIII).
If a device does not have a Notified Body number next to the CE mark on the labelling this is a hint that the device is a class I device (no measuring function, non-sterile, not reusable (MDR)).
Best regards,
Stefan
------------------------------
Dr. Stefan Menzl
Geschäftsführer / Executive Director
Qserve Group Deutschland GmbH
+49 152 900 28156
stefan.menzl@qservegroup.com------------------------------
Original Message:
Sent: 17-Jan-2019 08:46
From: Anonymous Member
Subject: CE-mark and Classification
This message was posted by a user wishing to remain anonymous
Hi everyone,
Does EU have a database similar to FDA's product classification database where if you type in the name of the device, you will get the classification as well? If we know a product is CE-marked, is there a way to find out what its classification is?
Thank you.