MDR/IVDR Insurance and Liability for Manufacturers, EU Representative and Importer

goldenguo

goldenguo

Involved In Discussions
Seems after MDR/IVDR release, EU Representative and Importer are very sensitive for their liability , and ask manufacture to buy enough insurance to cover the risk.
I do not know if there is any one know the detailed liability for EU Representative and Importer, what will happen if the manufacture did not buy insurance.
How to make EU Representative and Importer safe under MDR/IVDR?

In order to make this question clear ,I picked up all contents include insurance and liability in MDR.


All insurance appear in MDR
Article 10 General obligations of manufacturers

If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's successor in title, the patient's or user's health insurance company or other third parties affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.

Article 69 Damage compensation
1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical investigation conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk.

ANNEX VII REQUIREMENTS TO BE MET BY NOTIFIED BODIES
1.4. Liability
1.4.1. The notified body shall take out appropriate liability insurance for its conformity assessment activities, unless liability is assumed by the Member State in question in accordance with national law or that Member State is directly responsible for the conformity assessment.

1.4.2. The scope and overall financial value of the liability insurance shall correspond to the level and geographic scope of activities of the notified body and be commensurate with the risk profile of the devices certified by the notified body. The liability insurance shall cover cases where the notified body may be obliged to withdraw, restrict or suspend certificates.
4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article 69 and the corresponding national law.

All liability appear in MDR
Article 10 General obligations of manufacturers
16. Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law.
Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, 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.

Article 11 Authorised representative
5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer
 
B

Billy Milly

Involved In Discussions
It is in your text above :) EU based manufacturer shall have insurance. If the manufacturer is not in the EU, the AR will be held responsible - therefore, he should have the appropriate insurance.
 
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