Manufacturers, importers and suppliers of diagnostic equipment, point-of-care tests and related medical technology.

Where the sector’s exposures differ

An inaccurate result can lead to treatment delay, a patient injury allegation or a customer’s cost of repeating tests. These losses are not interchangeable. The device’s intended use, whether it analyses human specimens or operates directly on the patient, and any software component are important.

Insurance covers to assess

Consider products liability, product errors and omissions, professional indemnity for advice or calibration, recall and cyber risks where relevant. A supplier’s policy should not be assumed to cover a laboratory’s clinical interpretation. Research-use-only and clinical diagnostic supply must be described accurately.

Policy features to discuss

We can discuss the insured activities, insured entities, territorial limits, defence costs, excesses and aggregate limits offered by insurers. If a customer requests particular insurance, let us know so we can consider the available cover. Legal interpretation, drafting and negotiation of contracts should be handled by your legal adviser.

An illustrative exposure

A point-of-care test is alleged to give inaccurate readings. A clinic seeks repeat-testing costs while a patient alleges delayed treatment. Financial loss and injury need separate assessment.

This is a hypothetical example to explain cover questions, not a Mercantile client case or a paid claim. The proposed policy must be assessed before assuming any response.

Information needed for a quotation

Test purpose and users; sample types where relevant; validation and regulatory status; sensitivity to storage conditions; software and calibration responsibilities; device versus interpretation services.

Also provide turnover, wages, subcontractor and labour-hire costs, the legal entities to insure, existing schedules and wordings, claims or known circumstances, and planned changes. A clear activity breakdown helps us approach suitable markets and compare the terms offered.

Common questions

Is public liability enough for an incorrect diagnostic result?

Not necessarily. A claim involving only financial loss may require product errors and omissions or professional indemnity, depending on the alleged act and wording.

Can Mercantile review existing insurance?

Yes. Send the schedule and wording together with a description of your activities and key contracts. We can examine significant gaps and approach suitable insurers, subject to their appetite and acceptance. We assist Australian businesses from our Norwest NSW office.

Related insurance sectors

Our service focuses on insurance placement and policy cover. Product classification, approvals and regulatory compliance are matters for your regulatory adviser or the relevant authority.

Return to medical device insurance or explore all Life Science insurance sectors.

• Implantable Medical Device Insurance
• Surgical Equipment Insurance
• Invasive Medical Equipment Insurance

Prepared by Mercantile Insurance Brokers. Updated 30 September 2026. General information for Australian businesses. Availability and cover depend on insurer acceptance, policy terms, exclusions, limits and deductibles.