Product Liability

In the new Medical Device Regulations (MDR / IVDR) manufacturers will be properly obliged to take appropriate product liability (PL) insurance with sufficient minimum coverage - or arranging for an equivalent financial guarantee - to ensure that harmed patients are compensated for any damage and associated treatment as a result of a faulty medical device.

Objectives are focused to

  • cover the costs associated with defective devices
  • prevent that the risk of damage as well as the risk of the manufacturer's insolvency will not be shifted to harmed patients by a faulty medical device
  • prevent incidents such as the fraudulent PIP breast implant case.

Ref. Article 8 (par. 13) 

"Natural or legal persons may claim compensation for damage caused by a defective device  in accordance with applicable Union and national law."

"To this end, manufacturers shall consider taking out appropriate insurance or arranging for an equivalent financial guarantee, to cover the costs associated with defective devices."

Manufacturers should also consider Article 50d as damage compensation for patients from participating in clinical investigations.

Article 50d (par. 1)

"Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical investigation conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk."

As MRM we're able to work with global risk carriers of product liability specialized in medical technology / life sciences - including clinical trial coverage. By using our preferred global risk carriers and the I.N.I. Network we have the opportunity to work with a specialized and dedicated team of underwriters, loss control and claim staff to focus on your needs and requirements to protect your business and assets. We support you to be in compliance with the EU requirements and in arranging innovative insurance products tailored specifically for your company to protect you for unforeseen financial losses.

We support you to control i.e.:

  • General product liability insurance
  • Clinical Trial Insurance (eg. multicentre, multinational)
  • Recall
  • Supply chain
  • Liability claims
  • etc.

News

  • BREXIT impact
    How medical devices are currently regulated All medical devices are subject to EU legislation, which requires a manufacturer to place a CE mark on their product to attest compliance to applicable standards. Medical devices are regulated under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices…

Whitepaper