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Medical Device Distributor Agreements2026 Field Guide

The exclusivity levers, the exit duties, and the practice — with the deal work you need.

Exit tail
10/15 yrs
AR only
Art. 12
Exclusivity
Min. buy

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 exclusivity levers

The exclusivity levers: minimum purchase requirements, territory control, and reserved direct channels.

The exit duties

The exit duties: why Article 12 never applies to distributors — and the 10/15-year tail you keep.

The practice

The practice: term structure, registration ownership, and best-efforts promotion you can measure.

Sources & scope

  • meddeviceguide.com, Changing Device Distributors: Who Keeps Complaint and Traceability Files?
  • STAAR Surgical international distribution agreement (sec.gov EDGAR).
  • IR-MED distribution and license agreement (sec.gov EDGAR).

This guide is market-access intelligence, not legal or regulatory advice. Contract law, MDR duties, and enforcement practice change — professional review is required before business use.

Market Access Strategy Session

Distributor deals on your 2026 roadmap? Start with the full picture.

A Market Access Strategy Session maps your distributor route — feasibility-first vetting through hospital and doctor networks.

Professional review is required before business use.