Mercantile / Medical device
Invasive Medical Equipment Insurance
Companies manufacturing or supplying catheters, needles, surgical access products and other equipment used invasively. Review products liability, professional services and recall exposures with Mercantile Insurance Brokers.
Companies manufacturing or supplying catheters, needles, surgical access products and other equipment used invasively.
Where the sector’s exposures differ
How, where and for how long a product enters the body affects its risk. Sterility, material compatibility, packaging and instructions may be central to an injury allegation. Avoid describing all invasive products as a single uniform risk: transient-use products and long-term implanted products may need different underwriting.
Insurance covers to assess
We assess accepted products liability, product errors and omissions where appropriate, recall and any advice or services. Check exclusions relating to specified procedures, devices or materials, and whether contract manufacture, sterilisation or private-label supply is disclosed.
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 packaging defect is alleged to compromise a sterile catheter batch. Patient injury allegations and the expense of withdrawing unused units may engage different policies.
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
Product dimensions and intended application; contact duration; sterilisation method and provider; lot traceability; clinical or commercial stage; customer contracts and export markets.
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
Are all invasive products implantable devices?
No. Invasive describes entry into the body; products differ in intended purpose and duration of use. Regulatory classification and insurer acceptance should be checked for the specific device.
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.
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.