CE Marking of Face Mask

CE Marking for Face mask

Two types of EU legal Frameworks applicable for Face masks are:

Face Mask typeDirective /RegulationStandardNB involvementTesting Required
Surgical masksRegulation (EU) 2016/425EN 14683Not Needed By Independent Lab
Face maskRegulation (EU) 2017/745EN 149+ EN 14683In Design ExaminationBy NB laboratory

Face Mask Certification as PPE

Ce marking for Face mask under PPE

Can we Get Standards for Free?

Yes, manufacturers can download the standards EN 149 and EN 14683 for free from the online catalogs of the national standardization bodies. A full list, with links to the respective web-sites, is available at:

What are the Applicable Standards?

  • EN 149
  • EN 14683

Do we have to involve a Notified Body?

  • Yes, for FFP
  • No, for Surgical masks