FAQ

EU Authorised Representative (EU AR) — MDR/IVDR

Do we need an EU Authorised Representative?

If your company is established outside the EU and you place medical devices or IVDs on the EU market, MDR/IVDR typically requires you to appoint an EU Authorised Representative (EU AR). The exact obligations depend on your product and market model.

What does an EU AR do in practice?

• Acts as an EU contact point and supports communication with competent authorities (within the scope of the mandate).
• Coordinates availability of the documentation the EU AR must be able to provide upon request (as required by MDR/IVDR).
• Supports a practical workflow for updates, vigilance signals, and regulatory communication.

See details: EU AR for medical devices (MDR).

Can you act as EU AR for both MDR and IVDR?

Yes — we support manufacturers of medical devices (MDR) and IVDs (IVDR). We confirm scope during onboarding.

How quickly can we onboard?

Typical onboarding starts with a short scoping call and a document list. Timelines depend on product scope and readiness, but we usually respond to initial requests within 1–2 business days.

Are you registered in EUDAMED?

Yes. We are registered in EUDAMED as an Economic Operator (EO) — European Authorised Representative (EAR). View our EUDAMED entry.

PRRC

What is PRRC?

PRRC (Person Responsible for Regulatory Compliance) is a required role under MDR/IVDR for many manufacturers. The exact requirements depend on your organization and product scope.

Do you provide PRRC services?

Yes. We support PRRC implementation and working models. See: PRRC services.

Registrations & notifications

Do you help with EUDAMED?

Yes — we support data preparation and coordination for EUDAMED-related activities where applicable. See: EUDAMED support.

Do you help with CPNP?

Yes — for cosmetics-related workflows we can support CPNP notification preparation and coordination. See: CPNP notification support.

Commercial & practical

How much does it cost?

Pricing depends on the scope (EU AR only vs. EU AR + PRRC + registrations), device/IVD portfolio, and operational requirements. The fastest way is to submit a short request via Application — we reply with next steps.

What information do you need to provide a quote?

• Product type and basic classification information (if known)
• Markets (EU countries) and distribution model (importer/distributor)
• Company details and preferred start timeline

Do you sign NDAs / handle confidential information?

Yes. We treat information as confidential and can sign an NDA if needed during onboarding.

Which languages do you work in?

We work primarily in English. Other language versions of this website will be added later.

I’m not sure which service I need. What should I do?

Send a short description via Contact or Application. We confirm scope and propose the most practical path.