🎤  Edwin Waldbusser ‎       |  📅  March 28, 2023   |  🕒  11 AM Eastern Time US


The EU MDR replaced the MDD and expands the conformance requirements. Several parts of the MDR have been delayed for several years. New requirements are added and existing requirements are expanded. Emphasis is placed on lifecycle control and post market analysis. Reliance on “Substantial Equivalence” is discouraged. UID requirements are added. The supply chain has increased legal and regulatory responsibility.

Products intended to be imported into the EU must conform to these new regulations. Arrangements must be made with a Notified Body, an Authorized Representative and a Person Responsible for Regulatory Compliance. There is extensive preparation necessary. 

Areas Covered in the Session:

  • EU MDR objectives
  • QMS requirements
  • Device classification changes
  • Documentation requirements
  • Clinical evaluation requirements
  • UDI and labelling requirements
  • Post market surveillance
  • New Notified Body obligations
  • Human Factors/ Usability requirements

Who Should Attend:

  • Engineering Departments
  • Regulatory Affairs Departments
  • Quality Assurance Departments
  • Marketing Departments
  • Management
  • Importers of medical devices
  • Distributors of medical devices