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Medical device and medtech insurance is the set of covers a device maker needs for patient injury, clinical trials, design and software errors, recall and regulatory exposure. It matters because general manufacturing policies often exclude healthcare products.
Part of: Manufacturing insurance
In short
Medical device companies usually need product liability that expressly covers medical devices and the markets they sell into, separate clinical trials cover for each investigation, and PI or financial loss cover for design and software. In Great Britain, devices must conform to UK MDR 2002 and be registered with the MHRA before being placed on the market, with a UK Responsible Person for overseas manufacturers. Recall, cyber and D&O complete the programme. A broker can map each device, class and territory against the policies to find gaps.
A medical device or medtech company usually needs product liability written for healthcare use, clinical trials cover for any investigations, financial loss and professional indemnity for design and software, product recall, and the usual property, business interruption, cyber and management liability. The difference from general manufacturing is that the end user is a patient, the regulator is the MHRA, and a single design decision can affect every device in use.
This page sits alongside our guides to life sciences and biotech insurance and medical technology insurance. If your device relies on machine learning or clinical algorithms, see AI in healthcare and medtech insurance as well.
In Great Britain, devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended), known as UK MDR 2002. MHRA guidance notes that these regulations fall under the Consumer Protection Act 1987, and that once a device is on the market the manufacturer is responsible for monitoring it and reporting serious adverse incidents to the MHRA. Strengthened post-market surveillance requirements came into force on 16 June 2025.
According to the MHRA registration guidance, medical devices, including in vitro diagnostics, custom-made devices and systems or procedure packs, must be registered with the MHRA before they are placed on the market in Great Britain. A manufacturer based outside the UK must appoint a single UK Responsible Person, who takes on the registration duties.
For clinical investigations, MHRA guidance on clinical investigations in Great Britain says the manufacturer or UK Responsible Person must give 60 days' prior notice before a device for investigation is made available, and a research ethics committee opinion is required. The investigation can start once ethics approval is given and the MHRA has not objected.
Transitional rules for CE marked devices in Great Britain have changed several times. Check current MHRA guidance for your device class rather than relying on a date you have seen before.
| Cover | Typical trigger | Medtech points to check |
|---|---|---|
| Product liability | Patient or user injury, or property damage, caused by a defect | Healthcare and implant exclusions, US and Canada jurisdiction, retroactive date for long tail claims |
| Clinical trials | Injury to participants in a clinical investigation | Each study usually declared; country by country requirements; no-fault compensation wording |
| PI and financial loss | Design error, specification failure or a device that does not perform | Software as a medical device, efficacy wording, contractual liability |
| Product recall | Field safety corrective action or withdrawal | Whether a regulator notice is required; third party recall costs; replacement devices |
| Cyber | Data breach, ransomware, outage of connected devices or platforms | Patient data, connected device estate, regulatory investigation costs |
| D&O | Claims against directors, including regulatory investigations | Investor and funding round exposures, prospectus liability |
The split between PI and product liability is especially important in medtech. A device that injures a patient is a product liability claim. A diagnostic tool that gives a wrong reading, with no defect in the hardware, may be a financial loss or PI claim, or both.
Software that meets the definition of a medical device is regulated as one. For insurance, it raises three practical questions:
Our page on technology errors and omissions insurance explains how tech PI wordings usually treat software failure.
These examples are illustrative and do not describe any real business or claim.
Example 1: a wearable monitor. A UK company sells a Class IIa monitoring device to hospitals in the UK and the US. A sensor housing cracks in use and causes skin injuries to several patients. Product liability may respond, but US claims will only be covered if the policy jurisdiction includes the US. The cost of replacing housings across the installed base is a recall question.
Example 2: a first in human study. A startup notifies the MHRA of a clinical investigation at two NHS sites. Its existing product liability policy excludes clinical trials. A separate clinical trials policy, declared for that study, is needed before recruitment begins.
Example 3: a diagnostic algorithm. A software update changes a threshold, and a triage tool under-flags a condition for three weeks. No hardware is defective. The hospital trust claims its costs of recalling patients for review. This is likely to turn on PI or financial loss cover rather than product liability.
For the recall side, our product liability and recall toolkit and the manufacturing recall scenario are a useful starting point.
Apex arranges insurance for medical device and medtech companies; a broker reads every enquiry.
Yes. MHRA guidance says medical devices, including in vitro diagnostics, custom-made devices and procedure packs, must be registered before being placed on the market in Great Britain. A manufacturer based outside the UK must appoint a UK Responsible Person to carry out registration. Insurers commonly ask for confirmation of regulatory status at renewal.
Usually not. Many product liability policies exclude injury to participants in clinical trials or investigations. Clinical trials cover is normally arranged separately and declared study by study, with details of the device, participant numbers, sites and countries. Arrange it before recruitment begins, as cover is unlikely to apply retrospectively.
It depends on the wording. Some product liability policies are clear that software is a product; others are silent or exclude it. Where software performs a diagnostic or clinical function, many companies combine product liability with technology PI or financial loss cover so that both injury and pure financial loss claims are addressed, subject to the policy terms.
Because liability claims in the US and Canada can involve higher awards and defence costs. Many UK policies exclude North America unless it is declared, or include it with a lower limit. Insurers usually want to know direct and indirect sales into those markets, including through distributors and partners.
It is action a manufacturer takes to reduce the risk from a device already on the market, such as a recall, modification or updated instructions. A product recall policy may cover some of the costs, subject to its trigger and exclusions. Standard product liability usually does not.
Send us your current schedules or renewal pack and we will review the whole programme and tell you plainly what to keep and what to change. No fee and no obligation. Or call 0117 325 0027.
Book a programme review Get a quoteApex Insurance Brokers Limited is authorised and regulated by the Financial Conduct Authority. Registered in England and Wales, company number 07014570. This page is general information, not advice on your individual circumstances, and it does not guarantee that cover will be available or on what terms.
