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.
https://www.eu-esf.org/covid-19/4513-covid-19-suspicious-certificates-for-ppe
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
STEPS | ACTIVITY | CHARGES | |
Testing as per EN 14683:2005 excluding BFE and Biocompatibility (view the test plan below) | 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 |
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