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Chapter 28: Evolving Regulatory Landscape for Drug-Device Combination Products: Europe and Other Major Market Perspectives

  • Amanda MatthewsEmail author
  • Janine Jamieson
  • Steve Dew
Chapter
  • 83 Downloads
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)

Abstract

This chapter considers the changing regulatory framework for drug-device products in other major markets outside the USA, with specific focus on Europe. The chapter explores the evolving requirements across major regions, which have been driven by a want to converge and harmonize regulation and guidance, and specific international forums which have formed that are driving harmonization be examined. This chapter highlights the more recent overhaul in regulations in Europe. This has resulted in more rigorous scrutiny of medical device manufacturers and greater emphasis on patient safety. Specifically, it introduces new requirements for pharmaceutical companies developing drug-device products, requiring the need to obtain a third-party opinion on the medical device element as part of the product registration. Finally, the chapter considers industry perspective on harmonization efforts, the manufacturers’ evolving role to maintain compliance and life cycle management and how developments in specific guidance and standards for drug-device products could further facilitate global harmonization and convergence across major regulatory regions.

Keywords

Drug-device combination Europe Medicinal product Medical device Competent Authority Notified body Medical device regulation Lifecycle management 

Copyright information

© American Association of Pharmaceutical Scientists 2020

Authors and Affiliations

  1. 1.Global Regulatory Affairs, Medical Device and Combination Product CMC, Pfizer UK LtdSandwichUK
  2. 2.European Office, International Pharmaceutical QualityGothenburgSweden
  3. 3.Global Regulatory Affairs, Medical Devices and Combination Products, Biogen IncMaidenheadUK

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