Combination Products Under MDR (article 117)

3/22/2022 13:55 - 14:25

  • What is a combination product
  • The meaning of Article 117
  • The role and task of the Notified Body
  • Manufacturer responsibilities
  • Evidence and fulfilment of the GSPRs
  • Notified Body opinion

Heinrich Martens, Vice President Regulatory Affairs - BU Devices Pharmaceuticals and Devices Division, Fresenius Kabi