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THE INSURANCE CHECKLIST FOR MEDICAL DEVICE MANUFACTURERS
Why You Need a Medtech-Specific Insurance Checklist
Medical device manufacturing is not “standard manufacturing”. It is regulated, traceable, and highly sensitive to quality events. The insurance gaps that cause the biggest pain often appear when a company grows: new OEM contracts, export to new territories, new sterile packaging processes, new cleanroom classifications, or an expansion into design support and validation work.
This checklist is designed to help you identify what cover you need, what information insurers will ask for, and what common pitfalls to avoid — including the classic misunderstandings like “product liability covers recall” (it often doesn’t), or “our property policy covers contamination shutdown” (not necessarily).
Use this as a self-audit before renewal, before tendering for a new OEM contract, or when launching a new device line. If you want a broker to sanity-check your answers and build a combined programme, call Insure24 on 0330 127 2333.
Checklist 1: Confirm Your Role in the Supply Chain
Your “role” drives insurance. Are you the legal manufacturer? A contract manufacturer? A component supplier? A sterile packer? A distributor? Many businesses play more than one role depending on the product line. Your policies must match the truth, because insurers underwrite exposure based on what you do and where responsibility sits.
This checklist item matters because contract terms can shift liability. If your contract includes indemnities, hold harmless clauses, warranty obligations, or strict delivery penalties, you are carrying more exposure than your website description suggests.
- Are you the brand owner or legal manufacturer (UKCA/CE responsibility)?
- Do you manufacture for multiple OEM customers (contract manufacturing)?
- Do you supply components, sub-assemblies or finished devices?
- Do you perform sterile packaging, labelling or release activities?
- Do your contracts include indemnities, warranties or penalties?
- Do you export, and if so, which territories (EU/US/ROW)?
Checklist 2: Products & Public Liability — Limits, Territory, and Device Risk Class
Product liability should be tailored to your device risk profile and territories. Low-risk, non-invasive devices are underwritten differently from implantables, sterile devices, or critical care equipment. Export to the US can change underwriting appetite and pricing significantly. The policy wording and territory need to align with your actual distribution model.
A common mistake is having a policy that is “worldwide excluding USA/Canada” while your distributor quietly sells into the US, or having product liability that excludes certain device types or clinical use cases. Another common issue is poorly described activities — for example not declaring that you also provide labelling, packaging, or design support.
- Confirm device types, intended use and risk class are declared correctly
- Check territory matches reality (UK/EU/Worldwide/USA as required)
- Confirm limit of indemnity is contract-appropriate (per claim/aggregate)
- Check for exclusions related to implantables, sterile devices, or certain use cases
- Understand contractual indemnities vs what the policy will cover
- Make sure completed operations and long-tail exposure are addressed
Checklist 3: Recall / FSCA Cover
Recall and Field Safety Corrective Action costs can be huge — and they are not automatically covered by product liability. Even if no patient harm occurs, you may need to retrieve product, notify customers, manage regulator communications, dispose of stock, and produce replacements. In sterile manufacturing, a packaging defect can trigger a multi-lot correction programme.
The key questions are: what triggers cover, what costs are included, and what limits are adequate for your batch size and market reach. Recall cover is often the difference between “an expensive incident” and “a business-threatening event.”
- Do you have dedicated recall/FSCA cover, or only product liability?
- Are trigger definitions aligned to your QMS and regulatory workflow?
- Are notification, shipping, storage and disposal costs included?
- Are rework/replacement costs included (where required)?
- Does cover apply across all territories you sell into?
- Is the limit adequate for a worst-case batch size scenario?
Checklist 4: Cleanroom Contamination & Sterility Failure Exposure
Cleanroom and sterility risk often causes the “silent loss”: batch quarantine, scrap, shutdown and reputational damage. Standard property insurance doesn’t automatically cover contamination-driven shutdown. The right programme looks at your cleanroom classification, environmental controls, packaging validation, sterilisation dependencies and deviation/CAPA discipline.
This checklist item is about mapping the event sequence and making sure insurance responds where you think it will.
- Document cleanroom class, zoning and monitoring processes
- Identify high-value WIP/stock at risk during quarantine
- Confirm sterile barrier/packaging processes and validation controls
- Map outsourced sterilisation partners and dependency risk
- Review how shutdown and restart costs would be funded
- Ensure policy descriptions match sterile/cleanroom reality
Checklist 5: Professional Indemnity (Design, Specification, Validation & IFU)
If you provide design input, DFM guidance, technical documentation, validation protocols, or IFU/labelling review, you create PI exposure. Product liability focuses on injury/property damage. PI focuses on negligence allegations tied to professional services and financial loss. Many medtech contract disputes are “PI-style” disputes even if no patient harm occurred.
- List all professional services you provide to customers
- Check PI policy scope matches services (design/spec/validation/IFU)
- Review retroactive date and continuity (claims-made cover)
- Check contract caps and indemnities vs PI limits
- Identify subcontracted services (writers, translators, test houses)
- Ensure document control and change management are strong (underwriting)
Checklist 6: Property, Machinery & Stock Values (Including Customer Goods)
Cleanroom fit-outs and specialist equipment can be expensive to replace, and lead times can be long. Stock valuations are also frequently wrong: businesses understate WIP values, tooling values, or the value of customer-owned goods held on site. A combined review ensures buildings, contents, plant, tooling, and stock are all represented accurately.
- Confirm building/tenant improvement sums insured
- Capture cleanroom fit-out and environmental control system values
- List high-value machinery, tooling, test and calibration equipment
- Calculate realistic peak stock and WIP (not average)
- Declare customer-owned goods held under contract manufacturing
- Check storage conditions (sterile, temperature-sensitive, secure zones)
Checklist 7: Business Interruption & Contingent Dependency
Business interruption (BI) is where many manufacturers are underinsured. Medtech restart is often slower because you may need re-validation, re-certification, environmental monitoring stability, supplier requalification and documentation rebuild. Your indemnity period should be set to reality — not optimism.
Also consider contingent BI: dependency on sterilisers, critical component suppliers, and logistics routes.
- Set indemnity period to reflect regulated restart (often 12–24 months)
- Model worst-case downtime and loss of gross profit
- Consider increased cost of working (outsourcing, overtime, expedited freight)
- Identify dependency on sterilisation providers and critical suppliers
- Map single points of failure in equipment and facilities systems
- Check BI trigger assumptions in policy wording
Checklist 8: Cyber, Data, OT & QMS Systems
Medtech manufacturing relies on systems: QMS platforms, batch records, device history records, ERP/MRP, design files, labelling systems, and sometimes connected production equipment. A cyber incident can stop production and compromise compliance. Cyber cover can include incident response, recovery and business interruption options depending on insurer and policy structure.
- Identify critical systems: QMS, ERP, labelling, batch records, design files
- Check backup, segregation and recovery time objectives
- Assess ransomware exposure and supplier IT dependencies
- Consider cyber BI and incident response requirements
- Map third-party access (vendors, remote maintenance, contractors)
- Ensure cyber policy aligns with your operational reality (OT + IT)
Checklist 9: Employers’ Liability & Workforce Risk
Employers’ Liability is usually mandatory in the UK, but medtech workplaces have unique employee exposures: cleanroom ergonomics, repetitive tasks, manual handling, chemical exposures and maintenance activities. Insurers also care about agency staff and contractor management.
- Confirm employee categories and headcount/payroll information
- Review cleanroom ergonomics and RSI controls
- Check COSHH controls and health surveillance where relevant
- Assess contractor management and permit-to-work practices
- Confirm coverage approach for agency/labour-only workers (where applicable)
- Track incidents, near misses and corrective actions (underwriting confidence)
Checklist 10: Contracts, Evidence of Insurance & Renewal Readiness
Many medtech businesses only discover gaps when a customer asks for a certificate, endorsement or contract-specific requirement. Getting ahead of this is simple: maintain a renewal-ready pack that contains updated descriptions, limits, territories, and a summary of your controls. This also helps you negotiate better terms.
If you operate a combined package programme, renewals become easier: fewer insurers, consistent evidence, clearer accountability, and less “last-minute scramble” to satisfy customers and auditors.
- Create a one-page summary of products, processes, cleanroom and sterilisation model
- Maintain contracts register of insurance clauses and required limits
- Ensure certificates match required territories and limits
- Prepare claims/incident summary and improvement actions
- Update property/stock values and BI calculations annually
- Schedule renewal early (especially for high-risk devices or US exposure)
We thought we were well insured until an OEM asked for recall evidence, PI wording confirmation and a clear statement of territories. The checklist approach helped us fix gaps and structure a combined programme that actually matched our operations.
Operations Manager, Medical Device ManufacturerTURN THIS CHECKLIST INTO A QUOTE-READY PROGRAMME
- Identify gaps across liability, recall, PI, cyber, property and interruption
- Build a combined package aligned to medtech operations and contracts
- Prepare insurer-friendly underwriting submissions and evidence packs
- Structure limits, territories and endorsements that match your customers
- Support growth: new products, new territories, new cleanrooms and new OEM contracts
- One broker, one plan — with clear claims coordination
Compliance & Regulations
Insurance submissions are stronger when they reflect the control framework you already use. Underwriters typically respond well to:
- ISO 13485 quality management systems and controlled manufacturing processes
- UKCA / CE technical documentation and traceability expectations
- Complaint handling, vigilance and corrective action workflows (FSCA readiness)
- Cleanroom classification, monitoring and contamination controls
- Sterilisation validation governance and sterile barrier integrity controls
- Supplier qualification and subcontractor oversight
- Health & Safety controls supporting EL performance
- Document control, change management and training matrices
FREQUENTLY ASKED QUESTIONS
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What insurance does a medical device manufacturer typically need?
Most manufacturers need products/public liability, employers’ liability, and property/contents cover. Many also need recall/FSCA cover, business interruption, professional indemnity (if providing design/spec/validation/IFU work), cyber, machinery breakdown and transit cover depending on operations.
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Does product liability include recall costs?
Not automatically. Product liability is primarily designed for injury/property damage claims. Recall/FSCA costs usually require separate recall cover or specific policy extensions depending on the insurer.
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When do we need Professional Indemnity insurance?
If you provide design input, DFM guidance, validation documentation, regulatory support or IFU/labelling review, you create PI exposure. PI addresses negligence allegations linked to professional services and financial loss.
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How should we set business interruption indemnity periods for medtech?
Medtech restart can be slower because of validation, recertification and release evidence requirements. Many businesses choose 12–24 months depending on complexity, lead times for equipment, and supplier dependencies.
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What are common insurance gaps in contract manufacturing?
Common gaps include customer-owned goods not declared, recall exposure not insured, PI exposure from validation/documentation work, incorrect territories (especially US), and inadequate BI sums/indemnity periods for regulated restart.
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Do we need cyber insurance if we’re not a software company?
Many manufacturers rely on QMS, ERP, labelling systems and design files. A ransomware incident can stop production and compromise compliance. Cyber cover can include incident response and recovery support depending on policy.
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What do insurers need to quote medical device manufacturing insurance?
Typically: products and risk class, turnover split by territory, role (OEM vs contract manufacturer), processes (cleanroom/sterile packaging/sterilisation), claims history, property and stock values, BI details, and a summary of quality and safety controls.
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Can Insure24 help create a combined package for our business?
Yes. We can review your exposures and contracts, identify gaps, and structure a combined programme that coordinates liability, recall, property, BI and specialist add-ons such as PI and cyber.