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EU -FDA Registration

Surgical Face Mask CE Marking

Non Sterile Surgical Face Mask CE Marking and EU Registration is mandatory for marketing the medical device in 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 responsibility  and to be followed.

Face Mask CE Marking & EU Registration Process

Step I : Technical File Preparion and DOC Signing.

Manufacturer responsibility to keep final updated technical file ready with manufacturer & 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 in primary and secondary packing.

Step 3 : CE Compliance Certificate (Optional)

We are regulatory consultants and medical device CE Marking experts. We Issue CE Compliance Certificate after through inspection of Technical file.

Step 4 : 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 5 : 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.

Face Mask CE Marking & EU Registration Cost

  • Annual EU Representative Service Fees : 650 Euros
  • 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

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 teh claim of ``sterile`` to europe after EAR and EU Regisatrtion?

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