The Influence of MDR’s Article 117 in the Marketing of Combination Products

Regulatory Consulting

The European Union Medical Device Regulation’s (MDR) Article 117 brings improved patient safety measures with new implications for manufacturers, as they must fulfill a significant set of additional requirements.

Listen to the full episode on Veristat’s Advancing Revolutionary Therapies Podcast to learn more about the Article and its influence on the marketing of combination products.

Learning Points

  • What are Drug Device Combination (DDC) products
  • What is Article 117 of the MDR
  • The impact of Article 117 on Manufacturers

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