MDR / IVDR
EU AR for medical devices
EU Authorised Representative support for non‑EU manufacturers: structured communication workflow, EU contact point, and coordination around required documentation availability.
For non‑EU manufacturers selling in the EU, we provide EU Authorised Representative (EU AR) services and hands‑on compliance coordination.
Scopes we support include medical devices/IVD, cosmetics, REACH‑regulated products, and online marketplaces. We act as your EU contact point and keep the workflow clear — so you can operate in the EU market with less risk and admin burden.
Takes 2–3 minutes. No obligation.
NDA on request · Multilingual support · Clear deliverables before onboarding
getEAR.eu is a service of AFINA s.r.o.. We help non‑EU manufacturers meet EU representation obligations with a practical, business‑friendly approach — clear scope, clear workflow, and responsive communication.
EUDAMED-listed as an Economic Operator (EO) — European Authorised Representative (EAR): View our EUDAMED entry
EU Authorised Representative support for non‑EU manufacturers: structured communication workflow, EU contact point, and coordination around required documentation availability.
Help with PRRC requirements: defining scope and responsibilities, documenting the working model, and aligning PRRC tasks with your QMS processes.
Support with EUDAMED-related preparation and coordination: mapping required inputs, organizing data, and documenting submissions/updates.
Core service: EU Authorised Representative (EU AR). We also support additional EU representation roles and regulatory workflows across multiple product scopes.
Your EU contact point with an established communication workflow and ongoing support.
Responsible Person services and compliance coordination under Cosmetics Regulation (EC) 1223/2009.
Representation for non‑EU manufacturers under REACH (EC) 1907/2006.
Support for marketplace requirements and EU compliance signals needed to sell online.
Practical support to map obligations and prepare compliance documentation and processes.
Data preparation and coordination of CPNP notifications with the EU Responsible Person.
Support with documentation and process guidance for Certificate of Free Sale requests.
Send a short description — we confirm scope and propose a practical plan.
If your market entry also requires certification planning, testing, provider comparison, or a wider compliance route, use Eucertify.eu as the broader intake point.
You share your product type and target EU market — we confirm scope, eligibility, and the practical next steps.
We align deliverables, timelines, and responsibilities — then set up a clear communication workflow.
We coordinate required documentation availability and support registrations/notifications where applicable.
We stay available for updates and authority communication — keeping continuity over time.
Start with a short application. We typically respond within 1–2 business days.
Tell us your product type and target EU market. We reply in 1–2 business days.