Medical Equipment Right to Repair Act.

GENERAL ASSEMBLY OF NORTH CAROLINA
SESSION 2025
H 1
HOUSE BILL 460

Short Title: Medical Equipment Right to Repair Act. (Public)
Sponsors: Representatives Belk, Carney, Cunningham, and Buansi (Primary Sponsors).
For a complete list of sponsors, refer to the North Carolina General Assembly web site.
Referred to: Rules, Calendar, and Operations of the House
March 20, 2025
*H460-v-1*
A BILL TO BE ENTITLED 1
AN ACT TO REQUIRE OR IGINAL EQUIPMENT MAN UFACTURERS OF MEDICA L 2
IMAGING EQUIPMENT AN D MEDICAL RADIATION THERAPY EQUIPMENT TO 3
PROVIDE EQUIPMENT OW NERS AND REPAIR PROV IDERS ACCESS TO THE 4
SUPPORT DOCUMENTS, T OOLS, AND PARTS NECE SSARY TO PERFORM 5
DIAGNOSTIC, MAINTENANCE, AND REPAIR SERVICES ON THE EQUIPMENT. 6
The General Assembly of North Carolina enacts: 7
SECTION 1. Chapter 66 of the General Statutes is amended by adding a new Article 8
to read: 9
"Article 52. 10
"Medical Equipment Right to Repair Act. 11
"§ 66-503. Citation and definitions. 12
(a) This Article may be cited as the "Medical Equipment Right to Repair Act." 13
(b) As used in this Article, the following definitions apply unless context otherwise 14
requires: 15
(1) Authorized repair provider. – An individual or entity that has contracted with 16
an original equipment manufacture r to offer or perform diagnostic, 17
maintenance, or repair services of the ma nufacturer's medical imaging or 18
radiation therapy equipment whether operating under (i) a license to use the 19
manufacturer's trade name, service mark, or other proprietary identifier or (ii) 20
an alternative arrangement under which a provider offers to or provides 21
services on behalf of the manufacturer. For purposes of this Article, an 22
original equipment manufacturer that offers or performs diagnostic, 23
maintenance, or repair services of its own medical imaging or radiation 24
therapy equipment is also an authorized repair provider. 25
(2) Independent repair provider . – An individual or business that offers or 26
performs diagnostic, maintenance, or repair services of medical imaging or 27
radiation therapy equipment without contracting with the original equipment 28
manufacturer. 29
(3) Medical imaging equipment. – Any device used to view the human body to 30
diagnose, monitor, or treat medical conditions, including products for 31
ultrasound imaging, magnetic resonance imaging, medical X ray, 32
radiography, computed tomography, fluoroscopy, and mammography. 33
(4) Medical radiation therapy equipment. – Any device t hat produces high 34
energy-charged particles to provide radiation therapy and related support 35
General Assembly Of North Carolina Session 2025
Page 2 House Bill 460-First Edition
devices, including signal analysis and display equipment; patient and 1
equipment supports; treatment planning software; and component parts and 2
accessories. 3
(5) Original equipment manufacturer (OEM). – An individual or entity that is 4
engaged in the business of manufacturing and selling, leasing, or otherwise 5
supplying medical imaging and radiation therapy equipment to others. 6
(6) Owner. – An individual or entity t hat owns or leases medical imaging or 7
radiation therapy equipment. 8
(7) Part. – Any part made available by the original equipment manufacturer, 9
whether new or used, that is necessary for the maintenance or repair of medical 10
imaging or radiation therapy equipment. 11
(8) Support documentation. – Any manual, diagram, reporting output, service 12
code description, schematic diagram, security codes, passwords, or other 13
guidance or information necessary to perform diagnostic, maintenance, or 14
repair services on medical imaging and radiation therapy equipment. 15
(9) Tool. – Any software, hardware, or other apparatus necessary to perform 16
diagnostic, maintenance, or repair services on medical imaging and radiation 17
therapy equipment, including items needed to program or pair n ew parts, 18
calibrate functionality, conduct software updates, or perform any other 19
function required to bring the product back to fully functional condition. 20
"§ 66-503.1. Duties of original equipment manufacturer. 21
Any OEM that manufactur es medical imaging equipment or medical radiation therapy 22
equipment that is used in this State is required to do the following: 23
(1) Make available to any hospital or independent repair provider any support 24
documentation, parts, or tools necessary to perform diagnostic, maintenance, 25
or repair services of the manufacturer's medical imaging or radiation therapy 26
equipment subject to the following terms: 27
a. Anytime the OEM updates the support documentation for its 28
equipment, the OEM shall automatically send notice of the updated 29
information to all known equipment owners and independent repair 30
providers. 31
b. An OEM shall provide acce ss to support documentation at no charge 32
to an owner or independent repair provider, however , if the owner or 33
independent repair provider reque sts a printed copy of a support 34
document, the OEM may charge the owner or independent repair 35
provider the actual costs of printing and shipping the print copy. 36
c. An OEM shall provide access to tools without requiring authorization, 37
registration, or other such impediment to access or use necessary tools, 38
including impairing the ability to use the tools in an efficient and 39
cost-effective manner. The OEM shall make tools available at no cost 40
to an owner or independent re pair provider, however, the OEM may 41
charge an owner or independent repair provider the actual costs o f 42
preparing and shipping a tool. 43
d. An OEM shall provide access to any support documentation or tools 44
needed to access or reset any electronic security lock or any other 45
security-related function. 46
e. Both OEM and authorized repair providers shall provide access to 47
parts at the same costs and under the same terms as the most favorable 48
agreement between the OEM and any authorized repair provider. 49
General Assembly Of North Carolina Session 2025
House Bill 460-First Edition Page 3
(2) An OEM shall be in compliance with this section if the OEM dele gates the 1
requirements of this section to an authorized repair provider and the 2
authorized repair provider satisfies the requirements on behalf of the OEM. 3
(3) If an OEM offers training courses o r training materials on how to properly 4
operate, inspect, diagnose, maintain, or repair its equipment to authorized 5
repair providers, the OEM must offer the same courses or materials to owners 6
and independent repair providers. 7
"§ 66-503.2. Limitations and enforcement. 8
(a) Any violation of this Article is an unfair or deceptive trade practice for purposes of 9
Chapter 75 of the General Statutes, and the violating party is subject to suit thereunder by injured 10
parties and the Attorney General. 11
(b) Nothing in this Article shall be construed to require an OEM to divulge any trade 12
secret, as defined in G.S. 66-152, to an owner or independent repair provider. 13
(c) Any provision of an agreement between an OEM and an authorized repair provider 14
that purports to waive, avoid, restrict, or limit an OEM's obligation to comply with this Article is 15
void and unenforceable. 16
(d) No OEM or authorized repair provider shall be liable for any damage caused to 17
medical imaging or radiation therapy equipment or injury caused to an owner or independent 18
repair provider which occurs during repair, diagnosis, or maintenance of the equipment." 19
SECTION 2. This act becomes effective July 1, 2025, and applies to equipment in 20
use on or after that date. 21