Guide for IVD self-certified manufacturers

Are you a self-certified IVD manufacturer? 

What the upcoming In Vitro Diagnostic Device Regulation (IVDR) means for you and how you can prepare for it.

This guide includes the following:

  • Why is the IVDR necessary?
  • Most significant changes in the IVDR for currently self-certified IVD manufacturers
  • Increased Notified Body involvement
  • What to do next