EUDAMED
EUDAMED is the European Commission's central database for medical devices in the EU. It serves transparency, traceability, and market surveillance and comprises six modules:
1. Economic operators registration: manufacturers, EU authorised representatives, importers
2. UDI database: product registration with UDI/DI
3. Notified Bodies and certificates
4. Clinical investigations
5. Vigilance (incident reporting and field safety corrective actions)
6. Market surveillance
Under MDR (EU) 2017/745 (Art. 29-44), manufacturers must register their products in EUDAMED before placing them on the market. EUDAMED modules are being introduced progressively; mandatory use is being phased in module by module under Regulation (EU) 2024/1860. Until a module becomes mandatory, national registration obligations continue to apply.
Part of EUDAMED data is publicly accessible (e.g. the UDI database for products and operator data), enabling purchasers and users to verify the status of products.
EUDAMED was originally planned for 2020 but was introduced in stages due to technical delays.
Frequently asked questions
Who must register in EUDAMED?
Manufacturers, EU Authorised Representatives, and importers of medical devices active in the EU market must register in EUDAMED. Registration is a prerequisite for obtaining an SRN (Single Registration Number).
What is the SRN in EUDAMED?
The SRN (Single Registration Number) is the unique identifier for an economic operator in EUDAMED. It must appear on the labelling of certain medical devices and in the EU Declaration of Conformity.
Can you check in EUDAMED whether a medical device is approved?
Yes. The publicly accessible section of EUDAMED allows searches for registered products (UDI/DI) and economic operators. However, EUDAMED is not an approval register in the traditional sense - CE conformity is demonstrated by the EU Declaration of Conformity, not solely by a EUDAMED entry.