Module 17 2024

04/12/2024

EU Authorised Representative liability for defective devices

Multiple uncertainties for ARs

How to monitor and ensure Art.10 compliance of Manufacturer clients?

Legal basis for liability per MS?

AR obligation to terminate the mandate if Manufacturer acts contrary to its MDR obligations (Art.11(3)(h))

Notify reasons to national Authority and Notified Body (if relevant) (Art.11(6))

Failure to terminate promptly for cause will expose AR to liability for defective products

Manufacturer-AR relationship likely to be under significant tension under MDR AR will pass on cost of increased risk profile and resource requirements to Manufacturer clients Obligation to notify ex-Manufacturer client of complaints or reports of suspected incidents continues after termination

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EU MDR - SUD Reprocessors

“ Any natural or legal person who reprocesses a single-use device [SUD] to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to the traceability of the reprocessed device in accordance with Chapter III of this Regulation. The reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive 85/374/EEC” (Art.17 (2) MDR)

– Reprocessor name and address must be labelled / included in IFU – Name and address of original SUD Manufacturer removed from label but stays in IFU – Scope for MSs to prohibit or regulate more strictly – Revised EU PLD: anyone that substantially modifies a product outside the original manufacturer’s control is considered a “manufacturer” for purposes of claims

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