Manufacturer’s Insurance

How to choose the right insurance for the Medical Device Manufacturer?

Under the new MDR and IVDR 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.

How can we help?

The MDR Regulator company conducts consultations in order to select appropriate financial security that is able to meet the legal requirements for medical devices. We invite you to contact us in order to discuss details of our cooperation.