Medical device regulation & IVDR Transition Services
MakroCare global regulatory experts welcome the opportunity to discuss strategic options related to the new EU MDR and IVDR regulations, including the critical steps you should be taking now to realize successful outcomes

What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).Our IVD team has a broad range of industry and regulatory experience, and is able to offer CE certification services for IVD medical devices under the IVDR.