Surgical Face Mask CE Marking and EU Registration is mandatory for marketing the medical device in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices. As requirement of EU market these product should have CE mark and as CE mark medical device consultant we can help you in making the technical file for the same.
Face masks become a symbol in each pandemic period. It is very important to wear a mask for a viral enemy that is unclear where it will come from and is not visible even if it is not hidden. Although people sometimes use a scarf wrapped around their face or colorful homemade textiles that cover the mouth and nose, it is best to use masks or, more rarely, N95 masks for effective and healthy protection.
Surgical Face Mask CE Marking to be offered to users in the European Union countries must comply with the EN 14683 standard, which describes the requirements and test methods for carrying CE marking and medical face masks. This standard has been published in our country by the Turkish Standards Institute (TSE) TS EN 14683 Medical face masks – Requirements and test methods. Surgical masks are defined as medical equipment covering the mouth, nose and chin of the user according to the standard in question. Masks should act as a barrier between hospital staff and the patient, limiting the passage of an infectious agent. Masks should be produced according to different requirements and should be tested with the recommended methods to determine their performance.
The classification of masks is mainly based on the results of the following tests:
- Bacterial filtration efficiency test
- Breathability (delta P) test
- Splash resistance (synthetic blood) test
- Microbial cleaning test
- Biocompatibility test
The basic standard that must be complied with in order to put Surgical Face Mask CE Marking is the TS EN 149 standard (Respiratory protective devices – Half masks with filters for protection against particles – Properties, experiments and marking standard). This standard describes the minimum conditions for half masks with filters, respiratory equipment used for protection against particles that cannot be removed from the environment.
Surgical Face Mask CE Marking
Surgical Face Mask CE Marking as a medical device is theoretically possible but there is no standard for this and in the absence of a widely agreed performance benchmark the rules for CE marking medical devices, which require the manufacturer to have clear evidence that the device provides a medical benefit in response to one or more specific illness or disability, actually make it likely that it will cost more and take longer than the Notified Body procedure for PPE.
If the mask is intended to protect the patient, then the masks would be a Class I Medical Devices under the Medical Devices Regulations. The Regulation does not come into force until May of this year, however there is a derogation allowing it to be used in lieu of the old Directive and as such, we would strongly advise manufacturers to use the new Regulation.
Surgical masks conforming to EN 149 should fit tightly on the face and provide sealing between the face and the mask. In masks designed in this way, breathable air does not leak through the mask wall and passes through filter. For this reason, it is important that surgical masks pass the conformity test.
CE marking can now be placed on surgical masks that pass these tests under the responsibility of the manufacturer. Surgical Face Mask CE Marking services are also provided to our businesses within the scope of certification services.
Surgical Face Mask CE Marking is approved for safety, health and environmental protection standards. After tests performed in advanced laboratories, masks are classified as N95, N99 and N100 according to their level of efficiency, and CE marking is put on it by rating it as FFP1, FFP2 or FFP3.
For selling the device in EU market device provider should know the regulations ,our team of medical device regulatory consultant take lot of efforts to provide regulatory services to the clients.
