2026-03-19 2026-03-19 , online online, 1,290 € zzgl. MwSt. EUDAMED 2026 Readiness - Your To Dos by 28 May 2026

Be fully prepared for the mandatory EUDAMED go-live from 28 May 2026. The seminar provides a practical overview of key regulatory requirements and how to translate them into an actionable plan across Regulatory, Quality and IT. The focus is on SRN readiness, UDI master data design, data quality for large portfolios and reliable procedures for registrations, updates and certificate data.

Themen
  • Actor registration, SRN & sequencing
  • UDI master data: Basic UDI-DI, UDI-DI, variants, EMDN coding
  • Certificates, clinical investigations & vigilance workflows
  • Data lifecycle: registration, versioning, inactivation, legacy devices
  • Systems & interfaces: XML validation, ERP/PLM/QM integration
  • Automation: M2M eDelivery/AS4, high-volume transfers, data quality


Who should attend
This seminar is designed for RA and QA professionals, IT and data managers, as well as project leads who are responsible for planning, implementing and coordinating MDR/IVDR EUDAMED compliance within their organisations.

A basic understanding of medical device regulatory requirements is expected.
Ziel der Veranstaltung
Be fully prepared for the mandatory use of the first four EUDAMED modules from 28 May 2026: Actor Registration (SRN), UDI/Devices, Notified Bodies and Certificates, and Market Surveillance. This seminar will help you translate the regulatory requirements into a clear and structured action plan across Regulatory, Quality and IT. This includes SRN readiness, the design of UDI master data (Basic UDI DI, UDI DI, EMDN), data quality considerations for large portfolios and the establishment of reliable procedures for registrations, updates, versioning, inactivation, and linkages to certificates and vigilance records.
Teilnehmerkreis

  • Concrete "to dos" by date, role and system to meet the 28 May 2026 milestone, plus follow on deadlines for legacy devices and certificate uploads.
  • A pragmatic UDI data model for Basic UDI DI/UDI DI, multilingual naming and intended purpose; hands on EMDN coding practice and QA checks.
  • Proven error reduction tactics: XML validation to spec, interpreting error logs, and release/version control for smooth submissions.
  • Scalable operations: options for bulk upload and M2M automation via eDelivery/AS4, including access point setup, testing and release management.

EUDAMED-2026-Readiness

EUDAMED 2026 Readiness

Your To Dos by 28 May 2026

Benefits
  • Practical implementation steps
  • Direct reference to current deadlines
  • Tips for efficient data processes
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 26042503

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Alles auf einen Blick

Termin

15/04/2026

15/04/2026

Zeitraum

from 09:00 to 17:00

from 09:00 to 17:00
Veranstaltungsort

online

online

Gebühr
Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@forum-institut.de

Details

Be fully prepared for the mandatory EUDAMED go-live from 28 May 2026. The seminar provides a practical overview of key regulatory requirements and how to translate them into an actionable plan across Regulatory, Quality and IT. The focus is on SRN readiness, UDI master data design, data quality for large portfolios and reliable procedures for registrations, updates and certificate data.

Themen

  • Actor registration, SRN & sequencing
  • UDI master data: Basic UDI-DI, UDI-DI, variants, EMDN coding
  • Certificates, clinical investigations & vigilance workflows
  • Data lifecycle: registration, versioning, inactivation, legacy devices
  • Systems & interfaces: XML validation, ERP/PLM/QM integration
  • Automation: M2M eDelivery/AS4, high-volume transfers, data quality


Who should attend
This seminar is designed for RA and QA professionals, IT and data managers, as well as project leads who are responsible for planning, implementing and coordinating MDR/IVDR EUDAMED compliance within their organisations.

A basic understanding of medical device regulatory requirements is expected.

Ziel der Veranstaltung

Be fully prepared for the mandatory use of the first four EUDAMED modules from 28 May 2026: Actor Registration (SRN), UDI/Devices, Notified Bodies and Certificates, and Market Surveillance. This seminar will help you translate the regulatory requirements into a clear and structured action plan across Regulatory, Quality and IT. This includes SRN readiness, the design of UDI master data (Basic UDI DI, UDI DI, EMDN), data quality considerations for large portfolios and the establishment of reliable procedures for registrations, updates, versioning, inactivation, and linkages to certificates and vigilance records.

Teilnehmerkreis

  • Concrete "to dos" by date, role and system to meet the 28 May 2026 milestone, plus follow on deadlines for legacy devices and certificate uploads.
  • A pragmatic UDI data model for Basic UDI DI/UDI DI, multilingual naming and intended purpose; hands on EMDN coding practice and QA checks.
  • Proven error reduction tactics: XML validation to spec, interpreting error logs, and release/version control for smooth submissions.
  • Scalable operations: options for bulk upload and M2M automation via eDelivery/AS4, including access point setup, testing and release management.