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Technical File Preparation?

NIOSH Certification

The ultimate quality standard for N95 Face Mask. Get more details how the certification process and cost involved the NIOSH Certification of N95 Respirator.

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 US FDA Registration & Listing >>

Face Mask CE Marking & EU Registration Process

Step I : Technical File Preparion and DOC Signing.

It is the responsibility of the manufacturer responsibility to keep final updated technical file anytime and submit a copy with EU Representative (for Non-European manufactures)

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)

Once the registration number allocated by EU Authorities, EAR will issue EU registration Certificate as a proof Registration. This is an optional service for a fees of 200 Euros.

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

Pay and Start the Process

Is non sterile facemask classified as Class 1? Can it be Self Certified?

Yes, Facemask falls under Class 1. All type of class 1 devices are permitted to self Certify by EU as per 93/42/EEC.

Is Sterile facemask classified as Class 1? Can it be Self Certified?

No. Sterile surgical Facemask falls under Class Is. All type of class Is devices can be certified by NOTIFIED BODY.

How can I export facemask, coveroll, gown, etc (all class 1 devices) to Europe?

All non European manufactures can export after appointing EAR and completing the registration with EU authorities.

Is it possible to export sterile surgical facemask without the claim of ``sterile`` to Europe after EAR and EU Registration?

Yes, If the manufacturer does not claim the sterility feature even though you sterilized the device for better patient safety.

US FDA Medical Device Establishment Registration and Listing

The ultimate quality standard for N95 Face Mask. Get more details how the certification process and cost involved the NIOSH Certification of N95 Respirator.