MedicalMountains GmbH Implementation of the UDI according to EU-MDR - the database registration

target group

Product design, regulatory affairs, marketing.

content

The EU-MDR introduces the EUDAMED database for the central administration of medical devices in Europe. Included are stakeholders, product master data, approval by notified bodies, vigilance, clinical studies and market observation. All MDR products and MDD products with reporting requirements are affected. EUDAMED implements a workflow for product registration, certificate request and reporting. The seminar focuses on product registration according to UDI in GUDID (USA:FDA) and EUDAMED.

topic overview

• UDI at a glance: documentation, logistics, reporting, information
• UDI concept: marking, EUDAMED and dates
• Summary of product tagging from the previous day
• FDA GUDID: experiences and novelties
• EUDAMED database: Overview with an introduction to the modules SRN, Device, UDI, Certificate and Vigilance and their processes
• Group ID "BASIS-UDI-DI" in concept and implementation
• Hierarchy of packaging levels
• Multipacks and "kits"
• Fields and rules for products in the UDI module
• Overview for certificates, SSCP and vigilance reporting
• Communication with EUDAMED: computer connection, download or web forms

previous knowledge

Affinity for medical devices and databases. It is recommended to attend the seminar "Implementation of the UDI according to EU-MDR - the marking of medical devices" in advance.

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