CE Mark

Medical devices and diagnostics to be marketed in Europe are now required to have conformance to the Medical Device Directives (MDD) or Invitro Diagnostics Directives (IVDD) and to be CE marked. Regulatory Specialists, Inc. can assist with both the MDD, and IVDD classifications testing requirements, as well as obtaining CE certification through development of a Technical File.


  • Technical File
  • Notified Body Coordination
  • CE Labeling