Changing Notified Body

  • Due to the increased pressure from Competent Authorities, Notified Bodies (NoBo) show new strategies, focuses and behaviors
  • Even long lasting relationships with a NoBo and trouble free products may suddenly face difficult challenges from the NoBo
  • Some NoBo's have lost or are in the process of loosing their designation (i.e. the ability to "issue" CE marks).
  • Some NoBo's are struggling to demonstrate that they have competent, sufficiently trained experts to maintain specific product "codes" as per NBOG requirements
  • In any case, it is strongly recommended to revisit the choice of your NoBo

Which NoBo for the future ?

  • Medidee remains independent and does not have an agreement with a specific NoBo 
  • Medical device manufacturers using a small NoBo face an increased threat
  • However, the changes will also present difficulties to some important NoBos
  • The typically safe NoBos, like TüVSüd or BSI also face a strong increase in workload due to increased scrutiny from Competent Authorities and Clients transferring from other NoBos
  • The increased workload means that Technical File review or even audit planning can take double the expected time
  • Medidee recommends conducting a careful review of your Technical File prior to initiating a transfer procedure to a different NoBo