My Account
We compare quotes from leading insurers
A COMBINED INSURANCE PACKAGE BUILT FOR MEDTECH RISK
What Is a “Combined” Medical Device Manufacturing Insurance Package?
A combined insurance package brings your core business covers into a single, joined-up programme — rather than a patchwork of disconnected policies that may not align when a real incident happens. In medical device manufacturing, incidents rarely stay in one lane. A quality issue can become a recall; a recall can become a contract dispute; a contract dispute can become a PI claim; and a production interruption can create both first-party losses (stock, downtime) and third-party liabilities (failure to supply, customer remediation, litigation).
A combined package is not “one cheap policy”. It is a structured programme, usually led by a combined policy with extensions, plus specialist layers where required (for example: USA liability, Class III implantables, clinical trials, or dedicated recall). The goal is simple: reduce gaps, coordinate wordings, and make sure your risk transfer works the way you expect when you need it.
Insure24 designs combined programmes for medical device manufacturers, OEMs and contract manufacturers — including cleanroom assembly, sterile packaging, precision machining, electronics integration, moulding, and regulated warehousing/distribution.
Who Needs a Combined Package?
Combined packages are ideal for medtech businesses that have multiple moving parts: manufacturing + design input, cleanroom + warehousing, exporting + subcontractors, or multiple product lines with different risk classes. They are also valuable when your customers (OEMs, hospitals, distributors) request consistent evidence of cover: liability limits, endorsements, contract-friendly wordings, and named insured/additional insured requests.
If you’ve grown quickly, moved from prototype to production, added new territories, or shifted into contract manufacturing, your insurance often becomes fragmented: an old liability policy here, a basic property policy there, and ad-hoc extras as issues arise. That fragmentation can create gaps — especially around recall, professional services, and supply chain interruption.
A combined package is designed to keep pace with your operational reality and reduce “policy conflict” during a claim.
- Medical device manufacturers with cleanroom or controlled environment operations
- OEMs outsourcing production and managing multiple suppliers
- Contract manufacturers (CMOs/CDMOs) producing for multiple brands
- Businesses exporting to EU/US or supplying global distributors
- Manufacturers providing DFM, validation or regulatory support (PI exposure)
- Facilities with high-value stock, WIP, tooling or specialist machinery
- Businesses with strict customer contract requirements and insurance evidence demands
- Companies wanting fewer renewals, fewer insurers, and clearer accountability
Core Cover 1: Public & Products Liability (Including Completed Operations)
Product Liability is the backbone of most medtech insurance programmes. It responds when a product defect is alleged to have caused bodily injury or property damage. For medical devices, “defect” can include manufacturing errors, contamination, packaging failures, incorrect instructions, or component failures that affect patient outcomes. Completed operations matters because harm can occur long after the product has left your site.
In a combined package, liability cover should be aligned with your risk class, territories, and supply chain model. A policy that works for a low-risk device may not be suitable for implantables, invasive devices, sterile products, or devices used in critical care. Many claims begin as “quality complaints” and escalate quickly. A robust liability policy supports early defence, investigations, and legal strategy.
We also look at contractual risk: who is the legal manufacturer, who is the brand owner, and what indemnities are being accepted. Combined packages are designed to bring these realities into the underwriting conversation.
- Public liability for on-site visitors, contractors and operations
- Product liability for devices and components supplied
- Completed operations and long-tail exposure considerations
- Worldwide territory options (incl. USA/Canada where agreed)
- Defence costs and expert support
- Vendor/additional insured requirements (where achievable)
- Clear business description aligned to medtech activity
Core Cover 2: Product Recall / Field Safety Corrective Action
Medical devices are regulated products. When something goes wrong, the response is often governed by formal procedures: batch quarantine, complaint trending, investigation, and (where necessary) a recall or Field Safety Corrective Action (FSCA). Recall costs can become significant even before any injury claim is established: notifications, retrieval logistics, replacement manufacturing, disposal, crisis communications and regulatory liaison.
Many manufacturers assume product liability will cover recall costs — but recall costs are typically a separate insuring agreement. In a combined package, recall is either included as an extension (where suitable for the risk profile) or placed as a dedicated specialist policy that sits neatly alongside liability cover.
The key benefit of “combined” design is coordination: the recall trigger, definitions, and notification clauses are aligned with your compliance workflow, so you are not forced into risky delays when time is critical.
- Recall/FSCA costs (retrieval, shipping, storage and disposal)
- Notification costs (customers, distributors, end users as required)
- Investigation and root cause support (where covered)
- Replacement manufacturing and rework programmes (where covered)
- Packaging/label correction and relabelling programmes
- Crisis PR and reputation protection
- Multi-territory recall considerations for exporters
Core Cover 3: Property, Stock & Business Interruption
Medtech manufacturing often involves high-value assets: cleanroom fit-outs, specialist machinery, tooling, test equipment, calibration devices, environmental control systems, and valuable stock including WIP and finished goods. A fire, flood, or major breakdown can create immediate losses — but the bigger cost is often downtime, loss of revenue, and contractual strain.
Business interruption in regulated manufacturing is not just about “getting the lights back on”. It can involve re-validation, environmental recertification, tooling replacement, supplier requalification, and delayed release processes. Your indemnity period needs to reflect reality. Combined packages allow BI to be structured alongside your production and compliance workflows.
We also pay attention to customer goods and third-party stock. Many contract manufacturers hold OEM customer stock, components, or finished goods under bailment arrangements. That needs to be declared and insured correctly.
- Buildings and tenant improvements (where applicable)
- Contents including cleanroom fit-out, tooling and specialist equipment
- Stock, WIP and finished goods (incl. customer goods where declared)
- Business interruption and increased cost of working
- Consideration of extended indemnity periods for recertification/validation delays
- Contingent BI / supplier and customer dependency options
- Goods in transit and storage extensions (where needed)
Core Cover 4: Employers’ Liability
Employers’ Liability (EL) is a foundational requirement for most UK manufacturing businesses. In medtech, the workforce can be mixed: cleanroom operators, engineers, quality staff, warehouse and logistics teams, maintenance technicians, and office-based roles. Claims can arise from accidents, manual handling injuries, repetitive strain, slips/trips, and occupational illness allegations.
In combined programmes we ensure EL aligns with your reality: your employee categories, use of agency staff, contractors and labour-only arrangements, and site activities. This reduces the risk of problems when evidence is requested by customers or auditors, and helps keep the programme consistent at renewal.
For manufacturers that operate multiple sites or have staged expansions, a combined programme is a clean way to keep EL consistent while other covers are adjusted around growth.
- Workplace injury and occupational illness claims
- Legal defence costs and compensation awards
- Employee categories and headcount/ payroll declarations aligned to operations
- Consideration of agency and labour-only arrangements (where applicable)
- Support for multi-site operations and contract evidence requests
- Consistent approach with PL/Products wording for joined-up claims handling
Specialist Add-Ons That Often Sit Inside a Combined Programme
Combined packages are flexible. Some businesses need a “core combined” policy plus specialist extensions; others need a layered arrangement with separate specialist policies that still behave like one programme (same renewal date, coordinated claims approach, consistent evidence).
Common medtech add-ons include Professional Indemnity (for design/specification/validation), Cyber (especially where production and QMS systems are critical), Machinery Breakdown, Goods in Transit, and Directors’ & Officers’ liability for leadership risk. For higher-risk devices (Class III/implantables), clinical trials and expanded territorial coverage may also be relevant.
We’ll recommend what to include based on what you actually do — and what your contracts require.
- Professional Indemnity (design, specification, validation & IFU risk)
- Cyber insurance (incident response, recovery, business interruption options)
- Machinery breakdown (including environmental controls and sterilisation equipment)
- Goods in transit / stock in transit (including temperature-sensitive shipments where relevant)
- Management liability / Directors’ & Officers’ (where required)
- Clinical trials liability (for pre-market human studies)
- Global extensions including USA/Canada (subject to underwriting)
- Contractual requirements: additional insured, waiver of subrogation (where achievable)
Why a Combined Package Reduces Gaps
When insurance is fragmented, you can end up with overlapping policies — and also gaps. The most dangerous gaps occur where one policy assumes another will respond. Common “gap zones” in medtech include: recall vs product liability; PI vs product liability; cyber BI vs property BI; customer goods vs your own stock; and subcontractor errors vs your own operational liability.
A combined programme doesn’t guarantee everything is covered (no insurance does), but it makes the structure clearer and reduces the chance of mismatched definitions, conflicting notification duties, or different territorial boundaries.
It also improves efficiency: one renewal, one evidence pack, consistent insurer engagement, and clearer claims coordination.
- Aligned definitions and notification duties across covers
- Reduced conflicts between PL, Recall, PI and BI wording
- Clearer territorial structure for exporters
- Joined-up evidence of cover for customer contracts
- Better underwriting presentation of your full risk controls
- More consistent claims coordination and escalation
- Simplified renewal management and audit support
We needed one joined-up programme that covered liability, recall, property and interruption — and worked for both our OEM contracts and our cleanroom operations. Insure24 structured a combined package that reduced gaps and made renewals far easier.
Managing Director, UK Medical Device ManufacturerONE PROGRAMME. FEWER GAPS. CLEARER PROTECTION.
- A structured combined programme aligned to your actual processes and contracts
- Joined-up liability, recall and interruption protection
- Options for PI, cyber, machinery breakdown and transit cover
- Support for OEM/contract manufacturing models and customer evidence requirements
- Multi-territory solutions for exporters (UK/EU/US subject to underwriting)
- Simplified renewals, consistent documentation and clearer claims coordination
Compliance & Regulations
Medical device manufacturing operates under strict regulatory and quality frameworks. Combined insurance programmes work best when the insurer understands your control environment and how incidents are managed. We commonly align submissions with:
- ISO 13485 quality management systems
- UKCA / CE marking and technical documentation requirements
- Complaint handling, vigilance and corrective action workflows
- Cleanroom standards, environmental controls and contamination management
- Sterilisation validation and packaging sterile barrier controls
- Traceability, UDI, lot control and batch record integrity
- Supplier qualification and subcontractor oversight
- Health & Safety controls supporting Employers’ Liability performance
FREQUENTLY ASKED QUESTIONS
+-
What is a combined medical device manufacturing insurance package?
It’s a joined-up insurance programme that brings core covers (such as product/public liability, property, business interruption and employers’ liability) into one coordinated structure, with specialist add-ons like recall, PI or cyber where required.
+-
Is product recall included automatically?
Not always. Recall/FSCA cover may be included as an extension for certain risk profiles, but many medtech manufacturers benefit from a dedicated recall policy. We’ll recommend the right approach based on your products, territories and contracts.
+-
Do I still need Professional Indemnity if I’m “just a manufacturer”?
If you provide design input, DFM guidance, validation documentation, regulatory support, or IFU/labelling review, PI may be important. Product liability focuses on injury/property damage; PI focuses on negligence allegations linked to professional services and financial loss.
+-
How does a combined package help with customer contracts?
A combined programme can make it easier to provide consistent evidence of cover, align limits and territories, and support common contract requests (such as certificates, endorsements, and insurer-approved wordings), reducing friction with OEMs and distributors.
+-
What limit of liability is typical for medical device manufacturers?
Many programmes start around £2m–£5m and scale upwards depending on device risk class, turnover, contract requirements and export territories (especially the US). We’ll recommend limits based on your exposure profile.
+-
Does business interruption cover validation and recertification delays?
Standard BI cover is triggered by insured damage, but the indemnity period must be long enough to reflect regulated restart realities (recertification, tooling replacement, re-validation). We structure BI with realistic indemnity periods and dependencies where possible.
+-
Can a combined package include cyber and ransomware protection?
Yes. Many medtech manufacturers add cyber cover to protect QMS systems, batch records, design files and production continuity. Cyber cover can include incident response, recovery costs and business interruption options depending on the insurer.
+-
What do you need to quote a combined package?
Typically: your products and risk class, turnover split by territory, role (OEM vs contract manufacturer), key processes (cleanroom, sterilisation, packaging), claims history, property sums insured, stock/WIP values, business interruption details, and any contract requirements for limits or endorsements.