Slide 1 of 27 - [email protected] Article 2 – Definitions • (22) ‘distributor’ means any natural or legal person in the supply chain,

Slide 1 of 27

Robert Packard, Presidentwww.MedicalDeviceAcademy.com

[email protected]

EU Changes forImporters and Distributors

Slide 2 of 27


[email protected]

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


[email protected]


• (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


[email protected]


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

• Acronym…EOs

Slide 5 of 27


[email protected]

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


[email protected]

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


[email protected]

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


[email protected]

Article 25

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

Slide 9 of 27


[email protected]

New Obligations

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

Slide 10 of 27


[email protected]

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


[email protected]

Rob Packard

[email protected]

+1.802.281.4381

rob13485

Q & A

Slide 1 of 27 - [email protected] Article 2 – Definitions • (22) ‘distributor’ means any natural or legal person in the supply chain,

Documents