In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC

Such measures should be proportionate to the risk class, type of device and the size of the enterprise.

  • Product Liability Insurance (Recommendation)
  • Product Recall Insurance (Recommendation) and
  • Clinical Research Voluntary Patient Insurance (Mandatory)