Class II or Class III decides more about your program than your revenue does.

Products liability

Harm caused by the device in clinical use.

Without it — Long-tail claims that can arrive many years after implantation.

Product recall

Field actions, corrections and removals, which are frequent in this sector.

Without it — Device field actions are common and the liability policy does not fund them.

Professional liability for design

Errors in design, software or instructions for use, where the loss is not bodily injury.

Without it — Software-driven devices fail in ways a products form does not contemplate.

Clinical trial liability

Cover for the studies supporting the submission.

Without it — Required before the study can be approved.

Cyber, for connected devices

Breach and security failure where the device handles patient data or connects to a network.

Without it — A connected device is a data exposure and a device exposure at once.

How much does the device class matter?

A great deal, because it maps closely to how badly a failure ends. Class I devices with low patient contact are routine to place. Class II is the broad middle and depends on the specific device. Class III — implantable, life-sustaining, or supporting critical function — is a specialist market with materially higher pricing and fewer insurers. What underwriters ask beneath the class is whether it is implanted, whether it is life-sustaining, whether software controls anything clinical, and whether it is used at home by a layperson.

Are we liable if a hospital misuses it?

You can be, and this is where instructions for use and training become insurance documents rather than regulatory ones. Foreseeable misuse is a recognized theory of liability: if a clinician could reasonably use it the wrong way and the labelling did not adequately prevent that, the manufacturer is in the claim. Training records, IFU revisions and complaint handling are what defend it, and they are also what an underwriter reads.

We only distribute devices made abroad. Does that help?

It usually makes it worse, not better. A US distributor or importer of a foreign-manufactured device is frequently the only defendant a plaintiff can practically reach, and can be treated as a manufacturer for liability purposes. Relying on the overseas maker’s insurance rarely works: the policy may not respond in the US, the limits are shared with everyone else they supply, and enforcement is slow. Carry your own limits and read the distribution agreement’s indemnity carefully.