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Bill Summary · HB 460

Summary — HB 460: Medical Equipment Right to Repair Act

Status: Passed 1st Reading
Introduced: Nov 12, 2024
Subject areas: Commerce; Consumer protection; Health services; Medical equipment
Effective date (as written): July 1, 2025; applies to equipment in use on or after that date

Main purpose

The bill requires original equipment manufacturers (OEMs) of medical imaging and medical radiation‑therapy equipment used in the State to provide owners and independent repair providers access to the documentation, tools, and parts needed to diagnose, maintain, and repair that equipment. The intent is to expand repair options and reduce dependence on manufacturer‑authorized repair channels.

Key definitions (selected)

  • Medical imaging equipment: devices used to view the human body for diagnosis/monitoring (examples named: ultrasound, MRI, X‑ray, CT, fluoroscopy, mammography).
  • Medical radiation therapy equipment: devices that produce high‑energy charged particles for radiation therapy, plus related support devices and planning software.
  • OEM: entity that manufactures and supplies such equipment.
  • Owner: person or entity that owns or leases equipment.
  • Authorized repair provider: entity contracted by OEM to provide repair/maintenance services.
  • Independent repair provider: person or business that repairs equipment without an OEM contract.
  • Support documentation: manuals, schematics, service codes, passwords, etc., needed to perform repair/maintenance.
  • Tool: any software/hardware/apparatus required for programming, pairing, calibrating, or updating equipment.

Required OEM duties

  • Make support documentation, parts, and tools available to any hospital (owner) and independent repair provider necessary to perform diagnostic, maintenance, or repair services.
  • Provide updates to support documentation and automatically notify known equipment owners and independent repair providers when documentation is updated.
  • Make support documentation available at no charge (printed copies may incur actual printing/shipping costs).
  • Make tools available without authorization/registration barriers and at no charge (may charge actual preparation/shipping costs).
  • Provide access to documentation/tools needed to access or reset electronic security locks or other security‑related functions.
  • Make parts available to owners/independent providers on the same costs/terms as the OEM’s most favorable agreement with any authorized repair provider.
  • If OEMs delegate responsibilities to an authorized repair provider, that delegate can satisfy the OEM’s obligations.
  • If OEMs provide training to authorized repair providers, they must offer the same courses/materials to owners and independent repair providers.

Limitations, protections, and enforcement

  • Violations are treated as unfair or deceptive trade practices under the State’s Chapter 75 (allowing civil actions by injured parties and enforcement by the Attorney General).
  • OEMs are not required to disclose trade secrets (G.S. 66‑152) — trade secret protection preserved.
  • Contract terms attempting to waive or restrict the OEM’s obligations under this Act are void and unenforceable.
  • OEMs and authorized repair providers are not liable for damage or injury resulting from repair, diagnosis, or maintenance performed by owners or independent repair providers (bill provides a liability limitation in that context).

Who is affected

  • Directly affected: OEMs that manufacture/supply medical imaging and radiation therapy equipment used in the State; hospitals and other equipment owners; independent and authorized repair providers.
  • Indirectly affected: patients and health systems (through potential effects on equipment downtime, repair costs, and local service availability).

Practical impact and considerations

  • Expected to broaden access to repair information, parts, and tools — potentially reducing downtime and costs and increasing competition for repair services.
  • Preserves trade secret protection and contains a contractual‑waiver prohibition and a liability limitation for repair outcomes.
  • Enforcement is civil (UDTP claims and Attorney General enforcement); the bill does not prescribe specific administrative penalties beyond remedies available under Chapter 75.

Effective date and applicability

  • Becomes effective July 1, 2025, and applies to equipment in use on or after that date.

Compiled from official sources — confirm details with the bill’s official record.

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