+31(0) 74 750 8858 info@vaassen.net

CE Certifications

Legislation has been put into effect in the European Union for many product groups for which CE marking and the implementation of specific conformity procedures are mandatory. Our agency focuses on some of these product groups and conformity procedures and offers an extensive range of services. The following product groups fall under the expertise area of VTC.

  • Personal protective equipment - PPE Regulation (EU) 2016/425
  • Textile related medical devices Class I and IIa - Medical Devices Regulation (EU) 2017/745

VTC offers the following services :

  • advice in importing
  • compilation of the mandatory manufacturing files
  • product testing
  • advice, guidance and coordination of and in contact with Notified Bodies
  • advice, guidance and coordination in the registration of medical devices
  • EU representation