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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 conveys the tasks with EUDAMED from the manufacturer's point of view. It focuses on the strategic implementation of the MDR at the manufacturer or system and procedure pack producer.
topic overview
- MDR introduction: schedule, information sources MDCG and CAMD
- Overview UDI
- EUDAMED database: Overview with an introduction to the Actor, Device, UDI, Certificate and Vigilance modules and their processes
- Actor Registration Module: SRN and strategic considerations when making changes
- Vigilance Module: Create reports in EUDAMED
- Group ID "BASIS-UDI-DI" in concept and implementation
- Hierarchy of packaging levels and procedure packs
- Fields and rules for products in the UDI module
- Communication with EUDAMED: computer connection, download or web forms
target group
Regulatory Affairs, QM, Marketing
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.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
