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Is liability insurance mandatory for medical device manufacturers in the EU?

Medical device manufacturers operating in the European Union must comply with strict regulatory requirements to ensure patient safety and product reliability. One key aspect of these obligations is liability for defective products.

Understanding manufacturer’s liability under EU regulations

Two key legislative instruments define the liability obligations of manufacturers:

  • Council Directive 85/374/EEC (Product Liability Directive) – Holds manufacturers accountable for damages caused by defective products.
  • Medical Device Regulation (MDR) 2017/745 – Requires manufacturers to have adequate financial coverage for potential liability claims.

MDR requirements on financial coverage

The MDR 2017/745, particularly Recital 31 and Article 10(16), states that manufacturers must have financial measures in place to provide sufficient coverage for their liability under Directive 85/374/EEC. However, the regulation does not explicitly mandate liability insurance as the only means of fulfilling this requirement.

Instead, manufacturers can adopt alternative financial mechanisms, such as:

  • Self-insurance
  • Bank guarantees
  • Dedicated financial reserves

The MDR requires that these financial provisions be proportionate to the risk class of the device, the type of product, and the size of the manufacturer. High-risk devices (Class III) or large-scale manufacturers may need more extensive coverage than those producing low-risk (Class I) devices.

Do EU countries require liability insurance?

Although the EU MDR does not explicitly mandate liability insurance, some EU Member States have implemented national laws that make such insurance compulsory for medical device manufacturers. In some jurisdictions, regulators require proof of insurance or other financial coverage as part of the market authorization process.

National requirements for liability insurance

Certain EU countries require product liability insurance through their national legislation, particularly for high-risk devices or manufacturers without a physical presence in the EU. Countries such as France and Belgium have more stringent national laws that often push manufacturers toward obtaining insurance coverage to mitigate liability risks.

Practical considerations for manufacturers

Even if not explicitly required by law in every country, obtaining product liability insurance is considered a best practice for medical device manufacturers operating in the EU. It offers several advantages:

  • Legal Compliance – ensures financial preparedness to meet obligations under Directive 85/374/EEC and national laws.
  • Market Access – some Notified Bodies and Competent Authorities may require liability coverage as part of their conformity assessment procedures.
  • Risk Management – helps protect against costly legal claims and potential financial loss due to product defects.
  • Business Continuity – provides manufacturers with confidence that they can handle potential compensation claims without jeopardizing operations.

Manufacturers should assess their risk exposure to ensure they have adequate financial protection when marketing their devices in the EU.

Conclusion: is liability insurance mandatory?

Liability insurance is not explicitly mandated at the EU level, but manufacturers must have sufficient financial coverage to meet their obligations under MDR and the Product Liability Directive. Some EU countries require liability insurance through national laws, while in others, it is strongly recommended but not legally compulsory.

Ensuring compliance and risk management

To ensure compliance, medical device manufacturers should check both EU and national requirements and consider obtaining product liability insurance as a strategic risk management measure. While alternative financial coverage methods may be acceptable, having a dedicated liability insurance policy provides stronger protection against unforeseen legal and financial risks.

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Is liability insurance mandatory for medical device manufacturers in the EU?

Medical device manufacturers operating in the European Union must comply with strict regulatory requirements to ensure patient safety and product reliability. One key aspect of these obligations is liability for defective products.

Understanding manufacturer’s liability under EU regulations

Two key legislative instruments define the liability obligations of manufacturers:

  • Council Directive 85/374/EEC (Product Liability Directive) – Holds manufacturers accountable for damages caused by defective products.
  • Medical Device Regulation (MDR) 2017/745 – Requires manufacturers to have adequate financial coverage for potential liability claims.

MDR requirements on financial coverage

The MDR 2017/745, particularly Recital 31 and Article 10(16), states that manufacturers must have financial measures in place to provide sufficient coverage for their liability under Directive 85/374/EEC. However, the regulation does not explicitly mandate liability insurance as the only means of fulfilling this requirement.

Instead, manufacturers can adopt alternative financial mechanisms, such as:

  • Self-insurance
  • Bank guarantees
  • Dedicated financial reserves

The MDR requires that these financial provisions be proportionate to the risk class of the device, the type of product, and the size of the manufacturer. High-risk devices (Class III) or large-scale manufacturers may need more extensive coverage than those producing low-risk (Class I) devices.

Do EU countries require liability insurance?

Although the EU MDR does not explicitly mandate liability insurance, some EU Member States have implemented national laws that make such insurance compulsory for medical device manufacturers. In some jurisdictions, regulators require proof of insurance or other financial coverage as part of the market authorization process.

National requirements for liability insurance

Certain EU countries require product liability insurance through their national legislation, particularly for high-risk devices or manufacturers without a physical presence in the EU. Countries such as France and Belgium have more stringent national laws that often push manufacturers toward obtaining insurance coverage to mitigate liability risks.

Practical considerations for manufacturers

Even if not explicitly required by law in every country, obtaining product liability insurance is considered a best practice for medical device manufacturers operating in the EU. It offers several advantages:

  • Legal Compliance – ensures financial preparedness to meet obligations under Directive 85/374/EEC and national laws.
  • Market Access – some Notified Bodies and Competent Authorities may require liability coverage as part of their conformity assessment procedures.
  • Risk Management – helps protect against costly legal claims and potential financial loss due to product defects.
  • Business Continuity – provides manufacturers with confidence that they can handle potential compensation claims without jeopardizing operations.

Manufacturers should assess their risk exposure to ensure they have adequate financial protection when marketing their devices in the EU.

Conclusion: is liability insurance mandatory?

Liability insurance is not explicitly mandated at the EU level, but manufacturers must have sufficient financial coverage to meet their obligations under MDR and the Product Liability Directive. Some EU countries require liability insurance through national laws, while in others, it is strongly recommended but not legally compulsory.

Ensuring compliance and risk management

To ensure compliance, medical device manufacturers should check both EU and national requirements and consider obtaining product liability insurance as a strategic risk management measure. While alternative financial coverage methods may be acceptable, having a dedicated liability insurance policy provides stronger protection against unforeseen legal and financial risks.

Further reading

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI) - what is it, where to obtain it, and what to do with it

EUDAMED registration - a brief guide

Contract with the Authorised Representative in the European Union (Authorised Representative Mandate)

GSPR – General Safety and Performance Requirements for medical devices in the European Union

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

IEC 62304 - the pivotal standard for software medical devices

Medical Device Regulation (MDR) - basics

ISO and IEC standards for medical device software

Clinical Evaluation, PMCF, and PMS in Medical Device Lifecycle

Notified Bodies and their role in certification of medical devices

What is NANDO and why medical device companies should know about it?

Labeling and UDI requirements for medical devices in the EU

Understanding the roles of Authorised Representatives and Importers under MDR/IVDR

MDR implementation - challenges and solutions

Post-market surveillance under MDR and IVDR - requirements and best practices

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Risk management plan - guide for medical device companies

Should my medical device comply with GDPR?

EC-certificate for a medical device - Q&A

How long does it take to CE-mark a medical device?

What is a PRRC?

Essential requirements for importers and distributors under MDR and IVDR

Language requirements for IFUs and labels under the MDR and IVDR

Legal Manufacturer and Original Equipment Manufacturer in medical devices

How to structure a PRRC contract for effective compliance

How to Create a Declaration of Conformity According to MDR or IVDR

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Useful information

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

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We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
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