To ensure the safety and market readiness of their products, manufacturers of medical devices must demonstrate compliance with a number of regulations related to electromagnetic (EMC) compatibility, wireless performance, radio frequency (RF) exposure, and other safety and performance requirements. UL Solutions offers comprehensive support and guidance from design concept to product completion to help you avoid costly errors and accelerate speed to market.
Electromagnetic (EMC) incompatibility for healthcare products is prevalent and potentially life-threatening. In essence, it is difficult for products to be safety compliant and effective if they are not compatible with their intended environment.
EMC testing evaluates the interference potential between nearby products and the risk of injury or damage to persons or surroundings. These tests also determine compatibility between devices within their intended electromagnetic environment(s).
EMC and wireless requirements
Most countries impose EMC, wireless, radio frequency (RF) exposure and safety requirements. In the case of medical products, several standards guide testing, risk management, basic safety and essential performance. For example, medical products sold in the U.S. must comply with the IEC 60601-1-2 fourth edition, which defines the basic and essential performance of medical equipment in regard to emissions and immunity to electromagnetic disturbances. The U.S. Food and Drug Administration (FDA) will require compliance with edition 4.1 as of Dec. 17, 2023. Medical products entering the European Union that contain wireless functions must meet the ISO 14971 standard, Medical Devices — Application of Risk Management to Medical Devices. These and other standards impact how companies demonstrate compliance, manage transparency and evaluate products for potential risks.
Medical devices containing wireless features must meet Federal Communications Commission (FCC) requirements in North America and Innovation, Science and Economic Development (ISED) requirements in Canada. In the EU and U.K., devices are subject to Declaration of Conformity (DOC). In cases where a harmonized radio standard is not available or not applied in full, manufacturers must enlist an accredited Radio Equipment Directive Notified Body or, in the U.K., an accredited Radio Equipment Regulation approved body to review the technical documentation and issue a type examination certificate.
U.S. FDA’s ASCA Pilot Program
Manufacturers may choose to use one of the U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) accredited laboratories to conduct medical product testing for premarket submissions. When using a U.S. FDA ASCA accredited testing laboratory to perform testing, manufacturers can then use resulting documentation in their DOC, including any necessary supplemental information as part of the pre-submission. Participation in the U.S. FDA’s ASCA program can help:
- Reduce the chances of FDA reviewers requesting additional information to review and/or repeat testing.
- Enhance confidence in the medical device testing performed at the U.S. FDA ASCA accredited laboratory.
- Provide consistency and predictability in the premarket review process.
Why choose UL Solutions
Medical devices must undergo safety, EMC, and possibly wireless testing to meet regulatory and certification requirements. Understanding the regulatory landscape across regions and complying with disparate requirements can be daunting. We offer comprehensive support and guidance from design concept to product completion to help you avoid costly errors and accelerate speed to market. We can help you evaluate performance and demonstrate compliance in your product with flexible test plans tailored to your specific testing needs.
With teams of experts and more than a dozen U.S. FDA ASCA accredited laboratories around the world, we have the resources and experience to help you navigate the landscape of evolving requirements for healthcare products. We offer global, comprehensive testing and certification services throughout the entire production life cycle. Discover how our comprehensive electromagnetic compatibility and certification can help you achieve market readiness.