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Slide 1 of 27
Robert Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
EU Changes forImporters and Distributors
Slide 2 of 27
Robert Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
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)
Slide 3 of 27
Robert Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Article 2 – Definitions
• (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)
Slide 4 of 27
Robert Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Article 2 – Definitions
• (23) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor; (62 ‐ 0)
• Acronym…EOs
Slide 5 of 27
Robert Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
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
Slide 6 of 27
Robert Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
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
Slide 7 of 27
Robert Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
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
Slide 8 of 27
Robert Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Article 25
• Electronic System for Registration of EOs• Period of Review for Documentation and re‐evaluation is defined here
Slide 9 of 27
Robert Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
New Obligations
• Verification of Accuracy of Translations• Verification of Updating Documentation• New Supplier Agreements for EOs• Supplier Audits of EOs
Slide 10 of 27
Robert Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
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
Slide 11 of 27
Robert Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Rob Packard
rob@13485cert.com
+1.802.281.4381
rob13485
Q & A
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