Slide 1 of 27 - [email protected] Article 2 – Definitions...

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Robert Packard, Presidentwww.MedicalDeviceAcademy.com

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EU Changes forImporters and Distributors

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Article 2 – Definitions

• (21) ‘importer’ means any natural or legal person established within the Union who places a device from a third country on the Union market; (36 ‐ 0)

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• (22) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market; (23 – 1)

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• (23) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor; (62 ‐ 0)

• Acronym…EOs

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Article 11• General Obligations of Importers

– Assessment procedure was carried out– AR is designated– DoC & TF are created & maintained– Device bears CE– Labeling is compliant– UDI is assigned

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More Article 11…• Name• Trade Name• Address• Storage & Transport don’t jeopardize compliance• Carry out sample testing, investigate complaints, keep register of complaints, recalls and withdrawals

• Notify Mfg., AR and Distributor of Monitoring

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Article 12• General Obligations of Distributors

– Device bears CE– Product includes information required in ER 19– UDI is assigned

• Storage & Transport don’t jeopardize compliance

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Article 25

• Electronic System for Registration of EOs• Period of Review for Documentation and re‐evaluation is defined here

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New Obligations

• Verification of Accuracy of Translations• Verification of Updating Documentation• New Supplier Agreements for EOs• Supplier Audits of EOs

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Training Advice• Systematically create a training webinar on changes to regulations

• Create an exam to test each change• Split training into multiple 45 minute sessions

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Rob Packard

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+1.802.281.4381

rob13485

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