Article 13
Article 13: the verification duties before first placement — and when to refuse.
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EU MDR Importer Obligations2026 Field Guide
Article 13, verification, and the traceability chain — with the importer discipline you need.
- Obligations
- Art 13
- Registration
- EUDAMED
- Traceability
- Art 25
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.
Verification
Verification: EUDAMED registration, registers, complaint forwarding, and the product-release record.
The traceability chain
The traceability chain: Article 25 identification, the distributor trap, and storage/transport.
Sources & scope
- casusconsulting.com, 2026 EU MDR/IVDR: Importer Requirements & FAQs.
- meddeviceguide.com, Changing Device Distributors: Who Keeps Complaint and Traceability Files?
- brilitas.com, EUDAMED: Importers and Distributors.
- medium.com (freyrsolutionsm, Sep 2026), Freyr — Your Trusted EU Importer for EU MDR/IVDR Compliance.
This guide is market-access intelligence, not regulatory or legal advice. EU requirements, EUDAMED readiness, and competent-authority practice change — professional review is required before business use.
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