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Thursday, 15 October 2026 | 15:25 - 16:40

C2: IVDR: Regulatory deep dive, practical insights and key considerations for in-house IVD

Location:Room 5: Franz Joseph
  • 15:25: Elisabeth Jaeckle & Harald Guldan: Borderline cases: When classification gets tricky
  • 15:50: Andreas Oberleitner: The "Everyday Exemption”: In-House IVDs under the IVDR
  • 16:15: Simone Sturm-Emerstorfer & Lukas Katacic: Navigating Class D IVDR Certification – Best Practices

Andreas Oberleitner : The “Everyday Exemption”: In-House IVDs under the IVDR

In-house IVDs are often treated as a regulatory exception, yet in practice they are a widespread and essential part of diagnostic healthcare. This talk explores the current IVDR framework and national differences, the growing importance of in-house testing, proposed changes under IVDR 2.0, and best-practice examples of how efficient and compliant implementation could look like

5 speakers

  • Head of Business Unit IVD

    mdc medical device certification GmbH

  • Fachexpertin, Projektleitung / Expert, Project Management

    mdc medical device certification GmbH

  • Regulatory Affairs and Quality Management

    Ingenetix GmbH

  • VP Regulatory Affairs

    Platomics GmbH

  • Quality Manager

    Ingenetix GmbH