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Navigate The Regulatory Landscape For Drug Device Combination Products Under The EU MDR

Benchmark Regulatory Compliance. Improve Quality Management. Align With Industry Best Practices

Put Your Questions To Leading Competent Authority, Pharmaceutical And Medical Device Company Representatives

Deep Dive On Drug Device Combination Products

The EU MDR: Benchmark With Industry Leaders
  • Novartis share inside insights on how they achieved the first successful CE mark for their Concept1 inhaler
  • How are medicinal products, substance-based devices and combination products classified under EU MDR rule 21? Norgine provide clarification
  • Pfizer provide insights on the impact device safety and quality can have on drug efficacy
  • Abbott Molecular shine a light on global post market safety reporting
  • Lessons learnt and future opportunities for combination products: Put your questions to EISAI and Abbott Molecular in a focused panel discussion
The Current State Of Affairs
  • Competent Authority FAMHP break down the regulatory landscape for drug device combination products (DDCP) in the EU
  • What's are latest policy development in the United States? Get a direct update from the FDA
  • Examine the regulatory requirements for regenerative medicine and Advanced Therapy Medicinal Products (ATMPs) with EUCOPE
  • How does the EU MDR impact Drug Device Combination Products? Get a Notified Body overview with a focus on Article 117
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:

  • Get your questions answered in a Notified Body pain points panel in our EU Medical Device Regulation track
  • Join our EU Medical Device Law track for insights on legal obligations and responsibilities for combination products
  • Gain clarification on the classification of medical device software under the EU MDR in our Software and AI track
See The Full MedTech Summit Agenda