CE Certification for Face mask

With the increase in demand for Face Masks all over the world, there is also a increase in the problem of duplicate and bogus certificate.


The problem is compounded as there are many types of Face masks

While Surgical face mask can be certified as Class I medical devices this is not the case for respirator type of face masks

Med Devices has come up with a very clear cut Flow chart and steps for a genuine CE certification and Testing for Surgical Face mask with a clear cut pricing

A genuine CE certification would require the following STEPS

Testing as per EN 14683:2005(excluding BFE and Biocompatibility) Euro 400
Set up a IFU and Technical File Euro 300
Appoint a European Authorised Representative Euro 600
Get the Device Registered OR Euro 750
Ask the EAR to issue a Class I medical Device Certificate Euro 350
Total 0 Euro