EU Medical Device Regulations impact on Combination Products – What to be Aware of Across Drug Delivery Development

3/12/2019 16:55 - 17:40

  • Article 117 of EU MDR introduces the need for single integral medicinal products with a device component of class IIa and above to have a Notified Body opinion – what does this mean for combination product manufacturers? And what can manufacturers do to be ready for this change in regulations?
  • Notified Bodies will have to apply for MDR designation – what will the impact on this have on the availability of Notified Bodies to meet growing demands and timelines?
  • What will Rules on up classification mean for development and continued marketisation of Devices which will be up classified from class I to class IIa or b such as Rule 20 for inhalers?