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.
Step 2 : European Representative Agreement
Step 3 : CE Compliance Certificate (Optional)
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)
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