Module 16 2024

10/17/2024

PMS Requirements for Economic Operators (EO)

MDR Requirement

Importer (Art 13)

Distributor (Art 14)

EU- REP (Art 11)

Verify compliance to MDR Requirements

X

X

X

Keep copies of tech file, DoC and Certificates

X

X

Support request for commercial device samples or access to commercial device

X

Place name + address on Device, packaging or IFU

X

Verify device is registered (Art 29)

X

X

Ensure compliance with storage /shipping requirements

X

X

X

X

X

Forward complaints/suspected incident reports to EU REP & manufacturer

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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PMS Requirements for Economic Operators (EO)

MDR requirement

Importer (Art 13)

Distributor (Art 14)

EU- REP (Art 11)

Alert other EO/CA to non-conforming product

X

X

Keep Register of Complaints, Non-conforming product, recalls and withdrawals

X

Full cooperation with CA and Manufacturers

X

X

X

Meet traceability requirements

X

Verify UDI assignment where applicable

X

X

Shares liability for defective devices with legal manufacturer

X

Legend: CA = Competent Authority DoC = Declaration of Conformity EU-REP = European Authorized Representative EO = Economic Operator UDI = Unique Device Identifier

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

56

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