Surgical Face Mask CE Marking
Non-Sterile Surgical Face Mask CE Marking and EU Registration are mandatory for marketing medical devices in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices.
Since it falls under Class 1, Non-Sterile Surgical Mask can be self-Certified as per MDD 93/42/EEC. The following are manufacturers’ or importers’ responsibilities to be followed.
Sterile Surgical Mask is considered as Class Is so cannot be self Certified as per MDD 93/42/EEC.
Face Mask CE Marking & EU Registration Process
Step I : Technical File Preparion and DOC Signing.
Step 2 : European Representative Agreement
Non-European manufactures must appoint EU Representative and keep name and contact information on primary and secondary packing. Manufacturers must submit Declaration of Conformity to initiate the EAR agreement drafting.
Step 3 : EU Registration.
Register your device with any of the EU Authorities. This must be done by the EAR appointed by your organization for Non European manufactures.
Step 4 : Issue of EU Registration Certificate (By EAR)
Face Mask CE Marking & EU Registration Cost
- Annual EU Representative Service Fees : 650 Euros MDD / 850 Euros MDR
- EU Registration Service : 500 each Device
Optional service cost and timeline:
- Technical File : 2500 -3500 Euros depending on variants /models in 60 days time
- CE Compliance Certificate : 650 Euros
- EU Registration Certificate : 200 Euros
- Support in the development of Declaration Of Conformity (DOC) : 250 Euros
Is non sterile facemask classified as Class 1? Can it be Self Certified?
Is Sterile facemask classified as Class 1? Can it be Self Certified?
How can I export facemask, coveroll, gown, etc (all class 1 devices) to Europe?
Is it possible to export sterile surgical facemask without the claim of ``sterile`` to Europe after EAR and EU Registration?
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