Module 17 2024

Howard Dobbs

04/12/2024

MDCG Guidance

MDCG 2021-26 Title: Q&A on repackaging & relabelling activities under Article 16 of MDR and IVDR

MDCG 2021-27 Title: Q&A on Articles 13 & 14 of MDR and IVDR

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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Obligations of manufacturers MDR Articles 10, 11, 15, 29, 30, 52, etc

The OBLer will need to: - keep technical documentation up-to-date (Art 10.4) - obtain a UDI for the devices (Art 10.7) - have a full QMS (Art 10.9) - have a system for PMS and incident reporting (Art 10.10 & 10.13) - have an Authorised Rep, if not based in the EU (Art 11) - have a Person Responsible for Regulatory Compliance (Art 15) - register the devices in the electronic database (Art 29 and 30) - implement applicable Conformity Assessment procedures (Art 52) - etc

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

20

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