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A Structured Insurance Programme for MedTech Manufacturers
Medical device manufacturing combines engineering risk, product safety exposure, regulatory scrutiny and increasingly software and cyber complexity. As a result, there is no single “medical device insurance policy”. Instead, you need a structured programme of covers that work together.
This guide explains the essential covers most UK medical device manufacturers require, optional covers depending on device type and distribution model, and how to structure limits to avoid gaps between policies.
Core Insurance Covers Most Medical Device Manufacturers Need
These are the foundational policies that most manufacturers require, whether you produce Class I, II or III devices.
1️⃣ Product Liability Insurance
- Covers third-party injury or property damage claims
- Includes defence costs and damages (subject to wording)
- Often required at £5m–£10m+ limits by hospitals and distributors
- Applies whether defect is mechanical, electrical or software-driven
This is the most critical policy for any device manufacturer. Even where root cause is software or design-related, product liability may respond if bodily injury is alleged.
2️⃣ Employers’ Liability Insurance
- Legally required in the UK if you employ staff
- Typically written at £10m limit
- Covers employee injury/illness claims
- Relevant for production, lab and field engineers
Even low-risk cleanroom environments carry exposure from manual handling, chemicals, equipment and stress-related claims.
3️⃣ Public Liability Insurance
- Covers third-party injury/property damage not caused by products
- Relevant for site visits, trade shows and installations
- Often combined with product liability
Important where engineers install, service or demonstrate equipment at hospitals or clinics.
4️⃣ Product Recall / Field Safety Corrective Action
- Covers cost to retrieve, repair, replace or dispose of devices
- May include notification and crisis management
- Definitions of “defect” and “correction” are critical
Product liability does not pay for your own recall costs. This cover is essential for manufacturers with distributed installed bases.
Technology & Software-Related Covers
If your device includes firmware, algorithms, apps or cloud platforms, additional cover types become critical.
5️⃣ Technology E&O / Professional Indemnity
- Covers financial loss claims from software/design failure
- Responds to performance and contractual disputes
- Important where service/monitoring elements are included
Particularly important for connected devices, SaaS platforms and AI-driven systems.
6️⃣ Cyber Insurance
- Covers ransomware and cyber incident response
- May include breach response and regulatory support
- Includes cyber business interruption (subject to terms)
Even if you don’t store patient data, operational cyber disruption can halt production and release.
Property, Machinery & Business Interruption
7️⃣ Property & Contents Insurance
- Buildings (if owned)
- Plant, machinery and cleanroom equipment
- Stock and finished goods
- Office and IT equipment
8️⃣ Business Interruption
- Loss of gross profit following insured damage
- Extra expense and expedited costs
- Indemnity period typically 12–24 months+
Particularly important where specialist machinery or cleanroom capacity would take time to replace.
Additional Covers to Consider
Depending on your operations, you may also need:
- Directors & Officers (D&O) Insurance
- Goods in Transit / Export Insurance
- Clinical Trial Insurance (if applicable)
- Environmental & Pollution Liability
- Machinery Breakdown
FREQUENTLY ASKED QUESTIONS
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Is product liability mandatory?
It is not legally mandatory, but it is commercially essential. Most hospitals, distributors and procurement frameworks require evidence of product liability insurance.
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Do small start-up device manufacturers need all of these covers?
Start-ups still require product liability and employers’ liability (if employing staff). Other covers depend on device type, distribution model and contractual requirements.
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What limit of product liability should we buy?
Many medical device manufacturers purchase £5m–£10m+ limits, depending on device risk profile and customer contract requirements.
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Is cyber insurance necessary if we don’t store patient data?
Yes, because cyber risk includes operational disruption, ransomware and network security issues — not just data breach.
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Can Insure24 structure all covers under one programme?
Yes. We design coordinated insurance programmes for medical device manufacturers to reduce gaps between product, recall, technology and cyber exposures.