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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.
Two key legislative instruments define the liability obligations of manufacturers:
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:
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.
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.
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.
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:
Manufacturers should assess their risk exposure to ensure they have adequate financial protection when marketing their devices in the EU.
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.
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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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.
Two key legislative instruments define the liability obligations of manufacturers:
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:
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.
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.
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.
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:
Manufacturers should assess their risk exposure to ensure they have adequate financial protection when marketing their devices in the EU.
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.
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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