Medical devices—transitioning to the EU MDR and IVDR—training materials
Published by a LexisNexis Life Sciences expert
Last updated on 27/07/2020

The following Life Sciences precedent provides comprehensive and up to date legal information covering:

  • Medical devices—transitioning to the EU MDR and IVDR—training materials

Medical devices—transitioning to the EU MDR and IVDR—training materials

These training materials consist of template PowerPoint slides that can be used as the basis of one or more training seminars on Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR). It is anticipated that those providing training will use these slides as a helpful starting point for their presentations and then amend them accordingly to reflect their particular circumstances.

The training materials are customisable.

Click the links below to download the presentation.

Contents

  1. Introduction and rationale for the reform

  2. Key changes

  3. Scope and classification

  4. General safety and performance requirements

  5. Traceability—UDI

  6. Traceability—Registration

  7. Transparency—Eudamed

  8. Person responsible for regulatory compliance

  9. Clinical evaluation

  10. Post-market surveillance

  11. Vigilance

  12. Stricter rules regarding Notified Body

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