Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
Short answers about the EU Authorised Representative and PRRC roles under MDR/IVDR.
No. We are not a Notified Body and do not certify devices. We act as your EU Authorised Representative, a defined legal role under Article 11 MDR/IVDR, and can provide PRRC coverage under Article 15.
Every non-EU manufacturer placing a device in scope of MDR/IVDR needs an Authorised Representative. A separate PRRC is required only if you are a micro or small enterprise and want your Authorised Representative to provide that coverage under Article 15(6) - larger manufacturers typically keep the PRRC role in-house.
No. We accept an appointment only after a compliance review. Combination products, Annex XVI products and certain high-risk categories need an extended review before we quote representation.
We tell you what's missing and can support gap assessment and evidence strategy under the Market Access package.
getMDR.eu supports MDR/IVDR conformity assessment strategy and documentation readiness for the certification process. getEAR.eu is specifically the Authorised Representative and PRRC role for manufacturers established outside the EU.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.