Preparing to Change your European Notified Body

EU Losing Notified Body white paper

Questions? Request more information from our specialists


The transition deadline for the European Medical Devices Regulation (MDR 2017/745) will be here soon and medical device companies are preparing to recertify under the new regulation. However, some manufacturers could face another obstacle: losing their Notified Body (NB).

Some EU Notified Bodies may not continue their operations under the MDR, leaving their clients without a certification partner at this critical time. However, there are steps you can take to prepare for this possibility. In this white paper, we will discuss how to prepare to change your Notified Body. You will learn:

  • factors that might cause you to lose your NB
  • key signs that your NB is planning to withdraw
  • how to prepare to change your NB in time for MDR certification
  • considerations for choosing a new NB

You will learn all this and more in this 9-page white paper.