Module 17 2024

Howard Dobbs

04/12/2024

MDR: Certainties and uncertainties

• Based on Articles 10 and 16 of the MDR it is clear that the OBLer is required to:

- have a complete QMS (all parts of ISO 13485)

• Based on Articles 10 and 16 of the MDR it is not clear whether the OBLer is required to: − hold unredacted technical documentation − have a contract with the OEM − where applicable, be subject to NB audits including NB audits of the OEM and of the OEM’s critical suppliers

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

21

Conclusions based on the MDR

• If a distributor or an importer makes available on the market a device under its own name, or changes a device or its intended purpose, then all of the obligations of the manufacturer reside with the distributor or the importer. • If a distributor or an importer does not make available on the market a device under its own name, but relabels or repacks the device, then the obligations which reside with the distributor or the importer are much less. • Article 16 focuses on the requirements for relabellers and repackers and not on the requirements for OBLers. • Article 10 focuses on the requirements for manufacturers and therefore for OBLers

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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