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."

We can provide support to your insurance broker  to control i.e.:

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


  • UKRP-services
      The UK medical device regulatory system is independent of the European Economic Area (EEA). All medical device manufacturers will need to follow UK laws for (in vitro) medical devices, based on the EU regulations EU-MDR 2017/745 and EU-IVDR 2017/746. All non-UK manufacturers must have a UK-based UK Responsible Person…