Liability Insurance

Liability Insurance - MDR Art.10(16)/IVDR Art.10(15)

With the enforcement of the Regulation (EU) 2017/745 and 2017/746 for medical device and In-vitro Diagnostic Devices, it is obligatory for manufacturer of device to take Product Liability Insurance with ample coverage or arrange equivalent financial guarantee. This is to ensure that harmed and affected patients are reimbursed for any damage and associated treatment.

Important: check risk

Only the manufacturer of the device can correctly access whether the coverage obligation has been fulfilled in full. Only the manufacturer can determine what can go wrong with the product and what can happen if they are defective.

Maven Profcon Services LLP. can help you find the correct insurance provider and will act as a liaison between the manufacturer and the insurance provider.

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