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Product Liability Coverage for Medical Device Manufacturers

Did you know Admiral Insurance Group offers product liability coverage for Class I & Class II medical device manufacturers?

Billions of dollars are paid out as a result of medical lawsuits every year. And when someone is injured or doesn’t get the appropriate treatment, it is not just doctors and hospitals who are exposed. These lawsuits often name everyone who could bear some responsibility including medical device manufacturers.

This makes it extremely important for medical device manufacturers to have liability coverage in case their product injures someone, makes them sick, or does not work as intended and results in health issues. In addition to providing peace of mind and coverage when a device manufacturer is liable, one of the main advantages for liability coverage for device manufacturers is that the insurer often handles much of the litigation and settlement negotiations so the manufacturer doesn’t have to.

Medical Device Classifications

Whenever a new medical device or product is brought to market, it must first be classified and cleared by the FDA. The FDA divides medical devices into 3 basic categories based on the level of risk, which can vary widely from product to product:

  • Class 1: Low-risk devices such as bandages, gauze, scalpels, and swabs. 
  • Class 2: The largest category, this class covers a wide range of moderately low-risk devices including syringes, contact lenses, pregnancy test kits, defibrillators, ventilators, and diagnostic imaging machines.
  • Class 3: Medium to high-risk devices, which are typically implanted in the body, such as
    stents, pacemakers, and artificial joints.

Learn more about the medical device classification process.

Assessing Risk Exposure for Medical Devices

Due to the risks associated with Class 3 medical devices, including implantable devices, Admiral’s medical device liability coverage is focused on Class 1 and Class 2 devices only. Still, this leaves a wide range of products with a wide range of risk profiles that can be covered.

Assessing the risk profile of a particular product can be a complex task. Each device has unique risks associated with it, and some risks are more serious than others. For example, it is hard to envision how someone could get injured or become ill as a result of using a pregnancy test kit, whereas a wheelchair with faulty brakes could pose a serious risk of injury, and any device that requires power runs the risk of electric shock or fire from faulty wiring.

In order to calculate a medical device manufacturer’s risk exposure and write a policy that provides sufficient coverage with a premium that makes sense, it helps to have an expert underwriter on your side. 

If you are a wholesale broker in need of an insurance partner with deep expertise in the medical device industry, contact us to become an appointed broker. If you are a retail insurance broker with clients that include medical device manufacturers and distributors, we urge you to connect with one of our wholesale partners.

Products and services are provided by one or more insurance company subsidiaries of W. R. Berkley Corporation. Not all products and services are available in every jurisdiction, and the precise coverage afforded by any insurer is subject to the actual terms and conditions of the policies as issued. Certain coverages may be provided through surplus lines insurance company subsidiaries of W. R. Berkley Corporation through licensed surplus lines brokers. Surplus lines insurers do not generally participate in state guaranty funds and insureds are therefore not protected by such funds.


Andrea Dunn

Written by Andrea Dunn

Andrea Dunn is a Senior Underwriter for Admiral’s Health, Nutrition, and Lifestyle Team. She joined Admiral Insurance in 2015 and has close to 20 years of experience in commercial insurance underwriting. She is from New Jersey, close to Philadelphia, and is based out of the Mount Laurel office. When she is not working, Andrea enjoys spending time with family and friends. She is an avid Philadelphia sports fan and is enjoying attending games in-person.

Topics: dietary supplements, cbd, nutraceuticals, medical devices


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