GeneralAverage

Industry

What should I disclose before the first device shipment?

Before the first shipment, give the broker the device’s intended use, manufacturer and distributor roles, territory, and destination; add contract, installation, service, and transit details when they apply.

For devices or tools traveling to customers, ask which items, destinations, handlers, and trip stages are listed. California’s commercial guide treats movable property as distinct from property at a fixed site.[5]

Read the Medical Devices Insurance Buying Guide

Sources and Further Reading for Medical Devices

  1. Quality Management System Regulation (QMSR) — U.S. Food and Drug Administration. Effective-date statement; Applicability of the QMSR; CGMP Exemptions

    Confirm the stated finished-device manufacturer scope when describing your product stage; it does not determine insurance response.

  2. Overview of IVD Regulation — U.S. Food and Drug Administration. IVD definition and classification sections; FDA notes the overview is nonbinding

    Describe an in-vitro diagnostic product and its intended use when it is part of your device.

  3. Cybersecurity — National Association of Insurance Commissioners, Center for Insurance Policy and Research. Cyber risk categories and customized-policy qualification
  4. Cyber Insurance: Cybersecurity for Small Business — National Association of Insurance Commissioners. First-party and third-party coverage sections; vendor-held data and defense wording prompts
  5. Commercial Insurance Guide — California Department of Insurance. Commercial property; inland marine; boiler and machinery; commercial general liability

    Review California guidance on business property, liability, and movable property; compare it with the policy form.

  6. Small Business Insurance — National Association of Insurance Commissioners. General liability, products, and other business liability sections

Spot, a product of Tools for Enlightenment, publishes this guide and works in the commercial insurance market. This is general buyer education; policy terms and state-specific obligations determine coverage and requirements.

Updated 2026-09-28. Editorial Policy

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