The mandate and liability
Registration duties in the mandate.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
Before placing a device on the market, manufacturers, Authorised Representatives and importers register as economic operators in EUDAMED and receive a Single Registration Number (SRN). For non-EU manufacturers, the Authorised Representative is closely involved.
Within one week of any change to the registered information, the economic operator updates the data in EUDAMED. Not later than one year after submitting the information, and every second year thereafter, it confirms that the data is accurate.
EUDAMED is being made mandatory module by module under Regulation (EU) 2024/1860, which amended the MDR and IVDR to allow a gradual roll-out. Check the current status of each module on the European Commission's EUDAMED pages before planning registrations.
Authorities and Notified Bodies compare EUDAMED data with labels, the declaration of conformity and the mandate. Keep the Authorised Representative's name and address identical everywhere - see the Authorised Representative on the label.
The Single Registration Number issued by the competent authority after an economic operator registers in EUDAMED. Manufacturers use it when applying to a Notified Body and registering devices.
Within one week of any change to the registered information.
Yes. Authorised Representatives register as economic operators and verify that the manufacturer they represent has complied with its registration obligations.
Registration duties in the mandate.
Keep data consistent.
The role in plain language.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Specific obligations depend on your device and company structure. Last reviewed 30 September 2026.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.