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MedTech Summit
10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)
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10 - 14 June 2024
DoubleTree by Hilton Brussels City,
Brussels, Belgium (Hybrid Event)

MDR Article 117. Borderline Products Guidance. Regulatory Pathways: EU vs US. Get Your Head In The Game…

With guidance updates and feedback from the EU Commission, Ministry of Health, Notified Body and leading industry experts

BOOK NOWSee The Agenda

Navigate The Regulatory Requirements For Drug Device Combination and Borderline Products

Industry leading discussions from EU Commission, Notified Bodies and Industry Representatives

  • Guidance on classification and borderline products from the EU Commission and Dutch Health and Youth Care Inspectorate (IGJ)
  • Case study example from Novartis on obtaining NBOs under Article 117
  • Concise working group with Janssen on design control and development

Latest regulatory updates explained

  • Drug to device FDA status transition – who is affected?
  • Changes in classification guidance under Regulation (EU) 2017/745 on medical devices
  • Determining critical tasks for human factors validation tests

Elsewhere at the MedTech Summit...

Take a look at the 8 other MedTech Summit conference tracks to see what else is on the agenda for you:

  • Hear from Latham & Watkins on the legal challenges associated with combination products under MDR
  • Take a comprehensive dive into combination products under Article 117 with Fresenius Kabi Deutschland GmbH 
  • Discover best practices for successful implementation of PMS for DDCPs
See The Agenda

Elsewhere At MedTech Summit

European Medical Device Regulations

Software & AI for Medical Devices

Medical Device Law and Compliance

Post Market Surveillance and Vigilance

Clinical Evaluations & Investigations

Medical Device Regulations in Global Markets

EU IVD Regulation and Strategy

Biocompatibility for Medical Devices