Module 17 2024

Howard Dobbs

04/12/2024

MDCG Guidance MDCG 2018-6 Title: Clarification of UDI related responsibilities in relation to Article 16 of the MDR and the IVDR

• Any distributor, importer or other natural or legal person that assumes the obligations incumbent on manufacturers in accordance with Article 16(1), assumes all the relevant responsibilities related to UDI, including UDI labelling.

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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MDCG Guidance MDCG 2021-23

Title: Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of the MDR and of the IVDR. • The QMS must include procedures for translation, packaging and information exchange as already mentioned in Article 16.3, plus : 1. procedures for document control, resource management, internal audit, management review, complaints, CAPAs, traceability, etc 2. a contract between the repacker/relabeller and the OEM 3. a contract between the repacker/relabeller and a NB for auditing

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

18

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