The mandate
Article 11: the sole AR, the written mandate, the verification tasks — and what can never be transferred.
Free field guide · PDF
EU Authorized Representative2026 Field Guide
The mandate, the EUDAMED role, and the change playbook — with the EU practice you need.
- Mandate
- Art 11
- EUDAMED
- SRN
- Changes
- Art 12
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The EUDAMED role
The EUDAMED role: SRN registration, actor-request checks, and pre-placement device registration.
The change playbook
Article 12 changes: the three-party agreement, generic device groups, and the distributor-as-AR warning.
Sources & scope
- medium.com, EU Authorized Representative: What Non-EU Manufacturers Need to Know (Sep 2026).
- casusconsulting.com, How to Transfer your EU Authorized Representative.
- casusconsulting.com, EU Authorized Representative Service: Role of the EC Rep.
This guide is market-access intelligence, not regulatory or legal advice. EU AR requirements, EUDAMED procedures, and competent-authority practice change — professional review is required before business use.
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