Under the new MDR and IVD Regulations, users of medical devices can claim compensation for damage caused by a defective device.
Therefore, according to Article 10(16) of the MDR and Article 10(15) of the IVDR, medical device manufacturers should "have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law". These measures are to be proportionate to the risk class, the type of medical device and the size of the undertaking.