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 .


Who is liable for product defects?

The liability claim is usually brought against the manufacturing company. Along with the manufacturer, the authorized representative and the importer is also fined for any damages. To mitigate costs, it is necessary to choose an insurance that cover the maximum payable amount. This insurance must also cover for the affiliates as they are also liable for damages.

Why is insurance important?

Medical device manufacturers must have insurance in place to reduce the overall financial burden that a product defect may cause. The insurance cover depends on the level of risk a medical device may pose to the patient. For example, an implantable device like a pacemaker may cause a higher risk to the patient and therefore the insurance should cover for a higher amount. Whereas a device like surgical gauze does not require insurance that covers a huge amount.

How do I find out the insurance that best suits the company’s requirements?

In practice, the damages are primarily meant to compensate for any suffering caused. Manufacturers, therefore, need to evaluate certain aspects before choosing the best plan for the organisation. The value for compensation must be determined by:
·         The severity of the injuries (intensity of the pain, recovery time, etc.)
·         Consequential damage
·         Impairment of one’s personal or professional life
·         The injured person’s age
·         Level of culpability (degree of culpability, possible contributory negligence)
·         The financial status of the parties concerned (income, assets)