Does a US medical device liability policy cover claims from international sales?

Read the "coverage territory" definition in your general liability policy before you read anything else. On widely used US forms it does two things at once: it extends products and completed-operations coverage worldwide for products made or sold inside the United States, and then it narrows that extension by requiring that your responsibility to pay damages be determined in a suit brought within the United States or Canada, or in a settlement the insurer agrees to.

The practical effect is that "worldwide products coverage" often means "worldwide products coverage, adjudicated in North America." If your EU distributor is sued in an EU court and joins you, or an injured patient sues you directly where the device was used, the policy may not respond the way the plain-English summary suggested.

The forcing event is almost always a signed international distribution agreement. The distributor wants additional insured status, evidence of products liability at a stated limit, and often a commitment that coverage responds in their jurisdiction. That last item is the one a standard US policy may not deliver.

A distributor in a country that restricts non-admitted insurance may go further and require locally issued paper. Several jurisdictions prohibit or heavily restrict insurance written by a carrier not licensed in-country, which means a US certificate is not simply weaker there, it may not be usable at all.

Three things, in order. First, the coverage territory definition itself, including the suit-on-the-merits proviso. Second, whether any broadened or worldwide territory endorsement has been attached, and whether it extends to suits brought outside the US and Canada or only to the location of the injury. Third, whether defense costs are covered for a foreign proceeding, since defense outside your home jurisdiction is expensive and is sometimes handled differently from indemnity.

Check the same definition on the umbrella or excess layers. A broadened territory on the primary does nothing if the excess follows a narrower form, and following-form language does not always carry a manuscript endorsement upward.

A broadened coverage territory endorsement on the existing program, which is the lightest touch and is often available where the foreign exposure is modest and concentrated in stable jurisdictions.

An international liability program written alongside the domestic one, which is the common answer once foreign revenue is material or spread across several countries.

Locally admitted policies in the countries that require them, coordinated by a master policy above them. That structure is covered separately in the controlled master program and difference in conditions question below.

This is a territory question, not a limits question. Raising your products limit does nothing about a coverage territory that excludes the forum where you were sued. The two decisions are independent and are frequently confused during renewal.

It is also separate from regulatory compliance. Meeting EU financial-coverage obligations under the device regulation is a related but distinct requirement, addressed in the EU MDR question below.