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Medical Device Regulations EU/MDR & Legal Obligations for Liability Insurance;
In accordance with Article 10, natural or legal persons may claim compensation for damage caused by a defective device, in accordance with the relevant legislation. Manufacturers; In proportion to the risk class, type of device and the size of the enterprise, EU/MDR is in this article 85/374/EEC European Council Directive on Harmonization of the Legal and Administrative Regulations of the Member States on Liability for Defective Products, in the "Medical Device Regulation" published by the Ministry of Health in our country. and ensures that measures are in place to provide sufficient financial guarantee for its possible liabilities under the Product Safety and Technical Regulations Law No. 7223.
Product Liability Reasons for Damage:
Incorrect / incomplete labeling / packaging
Incorrect design
Insufficient promotion / use
Legally liable to pay as a result of the damages incurred by third parties during the use of the goods/products produced by the insured must compensate for the physical and/or material damages incurred.
Manufacturer
Dealer/Trader
Distributor
End seller
All kinds of material, moral and material and moral damages caused by product defects The producer is responsible for bodily harm before national and international laws.