You got from 5 to 7
A few steps away from the EU Market!
You are almost there – you have already completed a major part of the CE Marking process. There are just a few steps ahead to be undertaken and you will be ready to sell your devices to the European market!
Regardless of the class of your devices, you have to always make sure that the Technical File for each device is complete and bears all the evidence of conformity.
For upper class devices, manufacturers have to elect a Notified Body to audit their QMS and Technical File. If you need any help regarding building up or revising Technical File or if you have problems finding a suitable Notified Body, please feel free to contact us.
Obelis Group, professional EU Consultancy center, is currently supporting over 1000 Manufacturers in the compliance process and will gladly assist you in finding a Notified Body or reviewing your technical documentation.