Product Liability Insurance for Medical devices

Medical devices are subject to product defects. These product defects arise due to design, manufacturing or even a failed instruction for use of a product.

These defects can cause risks to patients, who in turn can sue the manufacturer for the damages caused. As medical device manufacturers, it is imperative to choose insurance that best covers themselves as well as their affiliates.

Product liability was brought in place to ensure that potentially unsafe products are discouraged from being placed in the market and manufacturers are held responsible for patient safety.

• Design defect: The product design does not meet the required general safety standards and performance requirements. Design defects can be identified with the help of testing standards. (Insert link for testing standards around the world post here)
• Manufacturing defect: Deviation from the standards set by the manufacturer during the manufacturing stage. Manufacturing defects can be minimized by having apt quality assurance and quality control measures.
• Instruction defect: Unclear explanation of how to use the product and the associated risks due to misuse of a product.

Economic Operator Obligations for Product Liability

As medical device manufacturers, numerous obligations have to be followed. These obligations are specified in Article 10 of EU MDR 2017/745, and that of Authorized representative and importer is mentioned in Articles 11 and 13, respectively. 

All these economic operators are liable for product damages. Point 16 of Manufacturer obligations (Article 10 of EU MDR 2017/745) explicitly mentions the requirement for insurance based on the risk class, type of device and size of the enterprise. The exact requirement also applies to Authorized Representatives (Point 5 Article 11). To understand all the other responsibilities of a medical device manufacturer, please read our article on manufacturer obligations .