Event 2nd Medical Devices: Regulatory and Compliance Summit

20 Feb 2020 - 21 Feb 2020

Meliá, Vienna, Austria

There’s less than one year left to EU MDR implementation. Are you ready? This process can be complex and challenging, and the 2nd Medical Devices: Regulatory and Compliance Summit is here to help.

This two-day event provides the appropriate platform for industry leaders and regulatory professionals to discuss the best practices for implementing MDR and IVDR in the EU. Held on February 20-21, 2020, in Vienna, Austria, this Summit will shed light on classification, conformity assessment and risk management in regulatory strategies to achieve compliance and ensure patients’ safety. Through case studies, interactive presentations and discussions, attendees will learn which regulatory strategy is applicable for their products, how to develop effective tactics and how best to achieve smooth market access. Besides sharing best practices, this event offers a valuable opportunity for network­ing and partnering with businesses of diverse sizes and types.

We are excited to be hosting this event and we look forward to meeting you in Vienna!

Key Practical Learning Points of the Summit

  • Overview of new guidelines, regulations and registration requirements
  • Notified body feedback on EU MDR implementation
  • Clinical affairs: data, evidence, equivalence and performance studies
  • Achieving a smooth market access
  • UDI implementation: challenges and opportunities
  • Risk management changes
  • Engaging medical device manufacturers with cybersecurity requirements
  • Practical insights from medical device manufacturers
  • Updating technical documentation and labelling
  • Classification of medical devices
  • Post-marketing adverse event reporting

If you have any comments or questions about the event, or if you want to publish your event on our event page, please feel free to contact us via info@medicaldevicescommunity.com. 

Regulatory and Compliance Summit

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