Preconference Workshop

Applied

EU MDR Annex II Technical Documentation Details: Too Much? Too Little? What is “Just Right”?

Workshop Leader(s)

• 

  Virginia Swassing, RAC (US and EU)

  Executive Director

Speaker(s)

• 

  Ibim Tariah, PhD

  Vice President of EU MDR and IVDR Consulting Services
  Regulatory & Quality Solutions LLC
• 

  Janet Michener Whipple

  Partner at Validant
  Validant

Facilitator(s)

• 

  Deborah Madsen

  Consultant
  Madsen QRC, LLC
• 

  Julien Senac, PhD

  Director, IVD Global Focus Team
• 

  Kimberly Snyder

  Senior Partner
  Validant

As the final year of the EU MDR transition commences, manufacturers are actively updating their existing device technical documentation. It is understood that the expectation is for the detail of the summary documentation to be greater than has been previously expected, but how much detail is enough? Manufacturers find themselves in a conundrum when choosing between explicit detail in the summary technical documentation (potentially hastening review and approval by the Notified Body) vs. driving resource efficiencies in maintenance of the information and global submission strategies. In this workshop we will dive into answer the question, “How much detail is sufficient?”

Agenda

Learning Objectives:

• Describe the appropriate level of detail to support the requirements of EU MDR Annex II.
• Provide examples of continuity of device information throughout the summary Technical Documentation and why this is important.
• Discuss practices to establish resources to maintain the documentation compliant to regulation.