What is an EU Authorised Representative?
Article 11 explained, and how it relates to the PRRC role.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
Educational pages and practical entry points for non-EU medical device and IVD manufacturers.
Article 11 explained, and how it relates to the PRRC role.
Start here if you are unsure whether Article 11 applies to you.
Article 15 requirements and the micro/small enterprise exemption.
MDR classes I-III and IVDR classes A-D.
Essential, EAR + PRRC and Market Access packages.
Detailed guides on specific Authorised Representative obligations and on selling from outside the EU.
Conformity assessment strategy and documentation readiness. On getMDR.eu.
For non-medical products in the same manufacturer's range. On getCE.eu.
For non-medical consumer products (GPSR does not apply to medical devices). On getGPSR.eu.
If the device also embeds a high-risk AI system. On representAI.eu.
If your product is actually a cosmetic rather than a medical device. On getCosmeticRP.eu.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.