Overview of class I and class II medical devices
The U.S. Federal Drug Administration (FDA) classifies medical devices into three classes: Class I, Class II, and Class III. The classification for a device depends upon the level of risk that is associated with the device.
Class I devices are considered to be at the lowest level of risk of all medical devices and are only required to comply with the lowest level of regulatory requirements. Whereas, Class II devices are considered to be at a higher risk than Class I devices and therefore require more stringent regulatory controls to prove their effectiveness and safety. Visit about UL’s Class III medical device capabilities page for more information and visit the U.S. FDA site for additional insights on medical devices overall.
Benefits of working with UL
We offer a comprehensive portfolio of services for the consumer retail wellness industry. Our team of experts leads the field in developing test methods to help retailers strengthen global compliance programs that include packaging evaluations, label reviews, quality assessments, and performance testing. Our quality assurance programs are designed to evaluate your entire operation with consumer and patient safety at the forefront.
Testing services for class I and class II medical devices
UL’s state-of-the-art laboratories offer a variety of testing solutions for Class I and II medical devices such as:
- Microbiological testing – Test for contamination by bacteria, yeast, mold, and other potentially hazardous pathogens in your Class I and II medical devices.
- Physical testing – Evaluate the physical characteristic of medical devices such as appearance, net contents, dimensions, and quality.
- Analytical testing – Identify the impurities in the raw materials that make up the medical device or the actual finished product.
- Performance testing – Access the performance of your medical devices with accelerated stress testing, benchmarking, failure analysis, aging and life-cycle testing and more.
- Packaging testing – Asses the packaging to help ensure there are no defects with the appearance and quality of the container.
- Label review – Review the labels to validate that all the necessary information is present such as country of origin, adequate directions, warning statements and more.
- Sensory testing – Trained judges evaluate the different sensory characteristics of the devices such as touch, taste, smell, sound and look.
Class I medical device products
The following products are designated Class I Medical devices:
- Bandages, tapes, wraps and gauze
- Braces, splints and slings
- Callus and wart remover pads
- Canes and accessories
- Crutches and accessories
- Dental flossers – floss and picks
- Dental wax
- Dosing syringes – cups and droppers
- Feminine hygiene pads
- Hot/cold packs
- Hot/cold water bottles
- Ice bags
- Incontinence products
- Interdental brushes
- Ketone test kits
- Toothbrushes – manual and electronic
- Urinary tract infection test kits
- Walkers and accessories
Class II medical device products
The following products are designated Class II Medical devices:
- Blood glucose monitor and strips
- Blood pressure monitors
- Compression socks
- Contact lens cleaning products and cases
- Electronic nasal aspirators
- Fecal occult blood test kits
- Heating pads
- Ovulation and pregnancy test kits
UL is a trusted name in consumer product testing, backed by our Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) registrations, as well as ISO 17025 accreditation. Our customized approach to addressing our clients’ problems also allows us to be flexible and provide testing programs tailored to fit your needs.
UL verified mark for class I and II medical devices
In an industry where brand and reputation mean everything, leverage the UL Verified Mark to differentiate your product by highlighting the quality. The UL Verified Mark program examines your product with UL’s most trusted science-based processes to verify your marketing claims, provide distinction and set your product apart in the market.