Medical Devices: expected bottlenecks for certification
Karin Schulze, SFL’s Head of Medical Devices & Combination Products, was recently interviewed by AWP Finanznachrichten on the challenges for Notified Bodies who are currently in the designation process due to the upcoming Medical Devices and In Vitro Diagnostics Regulations (MDR and IVDR). Notably, she highlights the possibility that the first Notified Bodies will not be designated before mid-2019, resulting in bottlenecks for the whole industry. The adoption of stricter requirements for designation of Notified Bodies under the MDR and IVDR risks, therefore, to delay the market entry of medical devices, thereby creating additional costs for manufacturers.
Read the full interview here (available in French only).