EUDAMED (European Database on Medical Devices)
EUDAMED (European Database on Medical Devices) is the central European database for medical devices established under the EU Medical Device Regulation (EU MDR 2017/745). It serves as a comprehensive information system for the registration of economic operators and products, the management of UDI (Unique Device Identification) data, the documentation of conformity assessments by Notified Bodies, the recording of vigilance reports, and post-market surveillance. Its goal is to increase transparency and improve market surveillance throughout the European Economic Area.
For manufacturers who have IFUs translated into multiple languages, EUDAMED is an important reference source: the market data stored there determines which language versions are required by regulation. Additionally, EUDAMED links each product version with its associated accompanying documents through the UDI system.
Frequently Asked Questions
What role does EUDAMED play in IFU translation?+
EUDAMED contains information about which EU Member States a medical device is placed on the market in. This directly determines into which official languages the instructions for use (IFU) must be translated. Manufacturers can systematically derive their translation requirements from EUDAMED registration data and ensure that all linguistic obligations under EU MDR Article 10(11) are met.