MDR Art. 10 (16) / IVDR Art. 10 (16)

Article 10 (16) of the MDR and Article 10 (15) of the IVDR have the same requirements.

They are both related to the financial coverage that a manufacturer shall have in place in case of a potential liability.

Both texts mention that natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law” (subparagraph 1).

And that 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.” (subparagraph 2).

As a reminder, Directive 85/374/EEC is related to the liability for defective products.

This means that the MDR and the IVDR do not introduce an obligatory insurance for the potential targets of lawsuits, but they introduce an obligation for manufacturers to form sufficient provisions or having evidence of a liability insurance policy

Note that both regulations do not mention similar provisions for authorised representatives.

Moreover, under section 4.3 of Annex XV (Clinical Investigations), Chapter II (Documentation regarding the Application for Clinical Investigation) of the MDR and of Annex XIV (Interventional Clinical Performance Studies and certain other Performance Studies), Chapter II (Documentation regarding the Application for Clinical Investigation) of the IVDR, manufacturers are pleased to have evidence of liability insurance cover for damage to participants in the clinical investigation/performance studies carried out for the purposes of certification, pursuant to the articles related to damage compensation (Article 69 of the MDR and Article 65 of the IVDR) and the corresponding national law. 

Note that notified bodies are obliged to take out liability insurance under section 1.4 of Annex VII of the MDR and of the IVDR.

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