Real or legal entities, in accordance with applicable Union legislation and national regulations, are now allowed to claim compensation for damage caused by a defective device in accordance with Council Directive 85/374/EEC (the regulation on liability for defective products in Member States). In this context, manufacturers must take the necessary measures to provide adequate financial guarantees.
Such measures should be proportional to the risk class, the type of device, and the size of the business.
- Product Liability Insurance (Recommendation)
- Product Recall Insurance (Recommendation)
- Clinical Trial Volunteer Patient Insurance (Mandatory)