Module 17 2024

04/12/2024

Supply chain potential product related liability broadened

Manufacturer, EU Authorised Representative, Importer

Distributor

Non-medical purpose device Manufacturer

Online seller Commercial online therapeutic or diagnostic services provider

EU MDR: Manufacturer of predicate products to which ‘equivalence’ is claimed

Reprocessor

Provider / User of a high-risk AI system for fault-based claims per EU AI Act and draft AI Liability Dir

TOPRA MSc Module 17

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EU Authorised Representative liability for defective devices

• “[…] Given that pivotal role [as an EU contact person and ensuring compliance of devices with MDR] , for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations [in Art.10] . The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC [old PLD] , and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer. (Recital (35))

− “[…] where the

manufacturer is not established in any

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, jointly and severally with, the manufacturer ” ( Article 11(5) MDR)

30

TOPRA MSc Module 17

30

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