Is your company established outside the EU?
If yes, continue. EU-established manufacturers do not need an Authorised Representative.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
The obligation under Article 11 MDR/IVDR applies to manufacturers established outside the EU that place a device in scope of the regulations on the EU market.
If yes, continue. EU-established manufacturers do not need an Authorised Representative.
Includes devices, accessories and certain products without an intended medical purpose listed in MDR Annex XVI.
If not, or if you are not sure, you need one before the device can be placed on the EU market.
You likely need an EU Authorised Representative → Check my device
Appointing an EU Authorised Representative is a separate service from the conformity assessment work itself. Regulatory strategy, technical documentation and Notified Body coordination are handled on getMDR.eu.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.