MDR Article 10(16) · IVDR Article 10(15)
Insurance should follow the risk, not merely tick the box
The EU requires sufficient financial coverage. It does not hand manufacturers a ready-made policy or a universal limit.
The difficult work sits between those two statements. A defensible arrangement must connect the product, possible harm, markets, policy wording and the company that actually carries the liability.
Build the coverage logic ↓Device exposure
Class · use · populationLiability scenario
Harm · territory · aggregationFinancial response
Limit · trigger · exclusionsThe 30-second answer
Insurance is the usual solution. “Sufficient financial coverage” is the legal requirement.
MDR Article 10(16) and IVDR Article 10(15) require every manufacturer to have measures that provide sufficient financial coverage for potential liability. The arrangement must be proportionate to the risk class, type of device and size of the enterprise.
The Regulations do not set one EU-wide euro amount and do not say that one standard insurance policy fits every manufacturer. National law can be more protective, while customers, authorised representatives, distributors and investors may impose additional contractual requirements.
Buying a policy is not the final step. The manufacturer must be able to explain why the insured entity, products, territories, limits, trigger and exclusions match the real exposure.
Three questions, three answers
Do not let one certificate answer the wrong question
Conformity, liability and insurance interact, but they are not interchangeable.
Does the device meet the MDR or IVDR?
Technical documentation, QMS, clinical or performance evidence, PMS and the applicable conformity-assessment route support the CE-marking decision.
Answer shown through the conformity fileWho may have to compensate the injured person?
EU and national liability rules determine the potentially responsible economic operator, compensable damage, evidence and available defences.
Answer determined by applicable law and factsWhich resources respond when a claim arrives?
The policy or other arrangement determines whether the event, entity, territory, timing and type of loss fall within the available financial protection.
Answer hidden in the coverage termsInteractive exposure lens
Change the product profile and the coverage questions change with it
This is not a limit calculator. It shows why a premium or insured amount cannot be selected from risk class alone.
Baseline review
Start with foreseeable injury, not annual revenue alone
Even a lower-class product may be sold in very high volume, used by vulnerable patients or create many related claims from one manufacturing defect.
What is the credible worst injury or property loss?
How many units and patients could share one defect?
Which countries and legal jurisdictions are exposed?
How long can a product remain in use and generate claims?
High-consequence exposure
One failure can be severe, while one cause can affect a cohort
Implant duration, life-sustaining use, explantation, revision procedures and common-component failures can turn a single technical issue into long-tail or aggregated exposure.
Does the trigger protect claims reported years after implantation?
Does one defect erode the aggregate limit across many claims?
Could revision, explantation or intensive care amplify damages?
What happens after discontinuation, acquisition or insolvency?
Digital exposure
The failure may sit in code, an update, data or a connected service
The revised EU product-liability framework expressly accommodates software. Coverage needs to follow the complete system rather than stop at the physical device boundary.
Are software, updates and cloud-dependent functions included?
Could a broad cyber exclusion remove bodily-injury cover?
Which policy year responds after a material update?
Do privacy, data restoration and product harm require separate covers?
Study-specific exposure
Clinical-investigation compensation is a separate design task
MDR Article 69 requires a compensation system appropriate to the nature and extent of risk. Country, protocol, sites, enrolment and sponsor–investigator arrangements shape the solution.
Which national compensation and ethics requirements apply?
Are every procedure, comparator and follow-up period declared?
Are sponsor, investigators and sites covered as required?
Is proof of cover valid before recruitment begins?
How much is sufficient?
There is no table to copy. Build a rationale that can survive a claim.
The risk class matters, but it is only one input. A credible analysis combines the severity and multiplicity of harm with commercial scale, geographic reach, product life and the way the policy limit is consumed.
The result should be a documented management decision supported by regulatory, legal, insurance and financial input. It should be reviewed when the exposure changes, not merely when the renewal email arrives.
Risk concentration
One implant, batch, software version or shared component may connect many claims.
Limit mechanics
Check per-claim, aggregate and sublimits, and whether defence costs reduce them.
Balance-sheet capacity
Identify deductibles, self-insured retention and losses intentionally kept by the company.
Change triggers
Reassess after a new class, claim, market, indication, acquisition or major sales increase.
Read the policy as a failure pathway
Eight clauses can matter more than the number on the certificate
A high limit attached to the wrong entity, product, country or trigger can provide very little usable protection.
- 01Insured
Correct legal entities
Manufacturer, group companies and any additional insured parties must match the actual economic-operator structure.
- 02Product
Complete insured portfolio
Descriptions should cover devices, accessories, software, versions, private labels and products no longer actively sold.
- 03Territory
Markets and jurisdictions
Worldwide sales language does not always mean that claims brought in every relevant jurisdiction are covered.
- 04Trigger
Occurrence or claims made
Understand which event fixes the policy year and preserve continuity, retroactive dates and extended reporting where needed.
- 05Limit
Per claim, aggregate and defence
Establish how related claims aggregate and whether legal costs sit inside or outside the insured limit.
- 06Retention
Deductible the company can fund
A technically insured loss can still create a liquidity problem if the retention applies repeatedly or is unusually high.
- 07Exclusions
No hidden removal of core risk
Inspect wording for implants, clinical trials, cyber events, PFAS, known circumstances, contractual liability and specific territories.
- 08Continuity
Tail and run-off protection
Long product lives require a plan for discontinuation, merger, insurer change and claims that emerge after market exit.
The adjacency problem
One incident can cross four policies and still find a gap
Ask the broker to map a realistic incident from first notification to patient claim, recall, cyber response and regulatory action.
Product liability
Bodily injury and covered property damage caused by a defective product.
Does not automatically cover the product itselfProduct recall
Withdrawal, notification, transport, disposal, replacement and crisis-management costs.
Often separate or tightly sublimitedCyber and technology
Security incident, data loss, service failure and technology errors or omissions.
Check bodily-injury and product exclusionsServices liability
Design advice, installation, training or other services that sit beside product supply.
May require professional indemnity coverFines, deliberate unlawful conduct, pure warranty costs and the cost of repairing the defective device itself are commonly outside ordinary product liability cover. The actual wording controls.
Follow the legal entity
The policy structure should mirror the supply-chain structure
Contracts can allocate risk between businesses, but they do not erase statutory duties or a claimant’s rights.
Owns the Article 10 obligation
The manufacturer must arrange sufficient financial coverage and remains responsible for the device even when design, production or distribution is outsourced.
May face conditional joint liability
For a non-EU manufacturer, Article 11(5) can make the authorised representative jointly and severally liable where the manufacturer has not complied with specified Article 10 obligations.
Have their own exposure
They do not automatically inherit the manufacturer’s Article 10 coverage duty, but national law, contracts and their own conduct can create liability.
Article 16 can change the role
An importer, distributor or other person may assume manufacturer obligations by marketing under its own name, changing the intended purpose or modifying the product in a way that may affect compliance.
Make the mandate, indemnity and insurance clauses tell the same story
- Which party must maintain which policy
- Required limit and duration
- Additional insured status where appropriate
- Evidence of renewal and notice of cancellation
- Indemnity scope and control of defence
- Survival after termination
The 2026 liability transition
The product file is becoming litigation infrastructure
Directive (EU) 2024/2853 modernises the EU product-liability framework. Member States must transpose it by 9 December 2026, and the new rules apply to products placed on the market or put into service after that date.
For medical technology, the practical direction is clear. Software is expressly treated as a product, relevant evidence can be subject to court-ordered disclosure, and presumptions can assist claimants who face excessive difficulty proving defect or causation because of technical or scientific complexity.
Review definitions, exclusions, notification procedures and limits before the new regime applies. A policy drafted around a purely physical product may not follow the actual digital lifecycle.
Earlier product-liability regime
The earlier Directive continues to govern products placed on the market or put into service before the transition point.
Revised national rules
Products placed on the market or put into service after 9 December 2026 fall within the national laws implementing Directive (EU) 2024/2853.
Preserve the evidence chain
Retain design, software, cybersecurity, PMS, vigilance, complaint, change-control and distribution records in a form that remains searchable and defensible.
The audit-ready coverage file
Keep the decision, not just the certificate
A one-page certificate rarely shows the exclusions, trigger, endorsements or analysis needed to defend sufficiency.
- 01
Exposure profile
Legal entities, device families, classes, intended uses, volumes, countries and product lifetimes.
- 02
Coverage rationale
Method, assumptions, scenarios and management approval supporting the chosen limit and structure.
- 03
Full policy wording
Schedule, definitions, exclusions, conditions, endorsements, sublimits and retroactive date.
- 04
Proof of placement
Certificate, premium status and broker or insurer confirmation for relevant entities and territories.
- 05
Contract map
Authorised representative, distributors, suppliers, private-label partners and indemnity arrangements.
- 06
Claims protocol
Who notifies whom, by when, with what records and under whose control of defence and settlement.
- 07
Review record
Annual reassessment plus event-driven reviews after portfolio, market, claims or ownership changes.
Practical questions
Liability insurance FAQ
Open the question that affects your next renewal, market entry or contract.
Does the MDR make product liability insurance mandatory?+
The MDR requires manufacturers to have measures that provide sufficient financial coverage for potential liability, proportionate to the risk class, device type and size of the enterprise. It does not prescribe one EU-wide insurance product or state that an insurance policy is the only possible measure. Product liability insurance is the usual practical mechanism, while national law or contractual requirements may be more specific or more protective.
Is there a minimum EU insurance limit for medical devices?+
No single minimum limit is stated in the MDR or IVDR. The manufacturer should determine and document why its coverage is sufficient for its own exposure, considering possible harm, risk class, device characteristics, sales volume, markets, product lifetime, claim aggregation and company resources. National requirements and contracts must also be checked.
Does the requirement apply to Class I devices and Class A IVDs?+
Yes. The financial-coverage obligation is a general manufacturer obligation, not a requirement triggered only by Notified Body involvement. A Class I device or Class A IVD may follow self-declaration, but the manufacturer still needs a proportionate and defensible financial-coverage arrangement.
Does a non-EU manufacturer need coverage for the EU market?+
Yes. A manufacturer placing a device on the Union market remains responsible for the applicable manufacturer obligations regardless of where it is established. Its authorised representative can also face conditional joint and several liability under MDR or IVDR Article 11(5), which is why the mandate, indemnities and the territorial scope of both parties’ insurance need to fit together.
Does product liability insurance normally pay recall costs?+
Not necessarily. A standard product liability policy may respond to covered third-party injury or property-damage claims but exclude the cost of withdrawing, replacing, repairing or disposing of the manufacturer’s own product. Product recall or contamination cover may need to be purchased separately and its trigger and sublimits reviewed carefully.
Is ordinary product liability cover enough for a clinical investigation?+
Do not assume so. MDR Article 69 requires a compensation system for damage suffered by a subject in a clinical investigation, using insurance, a guarantee or a similar arrangement appropriate to the nature and extent of the risk. The sponsor and investigator must use the system required in the country concerned. Study-specific cover and national rules therefore need a separate review.
Do CE marking or ISO 13485 certification prove that coverage is sufficient?+
No. CE marking, a Notified Body certificate and ISO 13485 address different questions. None automatically determines a suitable liability limit, territory, policy trigger or exclusions. The financial-coverage rationale should be reviewed as the portfolio, claims, markets and corporate structure change.
What should software and connected-device manufacturers check?+
They should confirm that the insured product definition includes software, updates, cloud-dependent functions and relevant digital services, and that cyber exclusions do not remove the central medical-device exposure. Product liability, technology errors and omissions, cyber and recall policies should be reviewed together so that an incident does not fall between them.
Primary sources
Verify the legal framework and then obtain policy-specific advice
This article provides regulatory orientation, not legal or insurance advice. National law and the complete policy wording must be reviewed for each manufacturer and market.
Regulation (EU) 2017/745
Articles 10(16), 11(5), 16 and 69
Regulation (EU) 2017/746
Articles 10(15), 11(5), 16 and 65
Directive (EU) 2024/2853
Revised liability rules for defective products
European Commission manufacturer factsheet
MDR implementation model and insurance reminder
MDCG 2022-16
Authorised representatives and Article 11 liability
The Blue Guide 2022
Economic operators, placing on the market and product liability
Turn the policy into a controlled decision
Need a regulatory exposure profile for your insurer or broker?
MDRC can map device classes, intended uses, markets, economic-operator roles, PMS signals and foreseeable exposure so that legal and insurance specialists can structure and test the coverage.
