Activity

  • asimbana replied to the topic Combination Products in EU in the forum EU Regulatory Basics 7 years, 8 months ago

    As mentioned be other fellow commentators, combinational medical device are much difficult to classify for those in the Notified Bodies, this is because according to the directives, the device would fall under either of the three categories, MDD, IVDD, and AIMDD. I currently do not have experience with comdinational medical devices but from what i have read and researched is that such device must first be investigated and identified what is the main objective of the product and how it is used. For example, for products such as a syringe with pre-filled solution such as collagen infused with antibiotics for 3D printing, the medical product would essentially be the collagen infused with antibiotics. The syringe and the printer would be in a way considered accessories.