The European Union has just published a draft of the latest In Vitro Diagnostic Regulation (IVDR). This set of much anticipated regulations provides IVD manufacturers with updated information as to how the new EU requirements will impact the CE Marking process for their devices.
What are the key elements of the new set of regulations? What will be the new requirements for IVD Manufacturers? How will these new regulations impact their CE Marking certification and compliance process?
Excel Translations brings you the highlights of the new IVDR, in a few simple bullet points.