Essentials of European Medical Device Regulatory Affairs - June 2020

Traceability

Traceability of devices to be kept for 10 years (15 years (implantable)) after last device placed on market

Economi c Operator

Economi c Operator

Health institute

Economic operator will need to record devices received and passed on

To record devices Eudamed database is being created with access to a free database so that a commondictionary is used for device types. https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

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Eudamed Will house • Device registrations • UDI data base • Registration of economic operators • Notified bodies and certificates • Clinical investigations • Vigilance and post market surveillance reports and summaries

• Commission and member states will have access • Others will have access to some • Meant to be fully functional by March 2021 .

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Guidance

 UDI number will need to be on the device, label or packaging

TheOrganisation for Professionals in Regulatory Affairs

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