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MDR 2017/745

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Guest user Created:   Mar 20, 2020 Last commented:   Mar 24, 2020

MDR 2017/745

Liability Insurance
what kind of insurance is that?
which insurance companies are available for that?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Mar 24, 2020

Liability insurance is designed to protect your property as a whole from claims by third parties. Your property is not physically insured under this policy, but it is protected from being reduced, as the insurer will pay out compensation to a third party on your behalf. This insurance protects your economic interest. 

In MDR, Article 10. General obligations of Manufacturers is stated that natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers must, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, take measures to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC (on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products).

A lot of different insurance companies can offer you this kind of insurance, so please look through the internet.

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Mar 20, 2020

Mar 24, 2020