Consulting for Medical Face Masks – CE marking & US FDA Registration & Listing

Purpose of Use: Medical Facial Masks are designed to prevent contamination of bacteria and similar pathogenic organisms within the body of the wearer to the environment or other people (patients) by the wearer’s breathing, cough, sneezing. It is also possible to protect the wearer from pathogenic organisms in the environment. (In the process of the Covid19 struggle, our people are recommended to wear in crowded environments.)

Product Structure and Production: Medical Facial Masks are generally produced in a structure consisting of 3 layers. Layers 1 and 3 are made of nonwoven fabric (Spunlaid – Nonwoven), designed to physically protect the fabric (Meltblow) in the middle layer and functioning against water / moisture. The performance of the product may vary according to the performance, thickness, general design of the fabrics and the technology of joining these layers.

Product Standard and Performance: Medical Facial Masks, which are subject to the Medical Devices Regulation, must be produced according to EN 14683:2019 standard and must have CE mark indicating that they comply with this standard and the Medical Devices Directive for EU & Listed in USFDA for US market.

Performance of Medical Facial Masks: EN 14683 standard defines the properties and performance requirements of the product. The products are tested according to these requirements and their performance levels are determined. The table below shows the experiment and performance limits used in the classification of the product. (In the Covid19 fight, patients or other healthy people are considered to be adequate for Type I use. Health professionals are advised to use Type II or Type IIR.)

ExperimentType IType IIType IIR
Bacterial Filtration Efficiency (%) (Minimum)959898
Change Pressure (Pa / cm2) (Maximum)404060
Droplet Resistance Pressure (kPa) At Least16
Microbial Cleaning (cfu / g) (Maximum)303030

As a result of the experiments, the results obtained outside the limits given above cannot be qualified in accordance with this standard.

Legislation that the product is subject to: Medical Facial Masks are defined as Class I in the Medical Devices Directive (EU) & Class 1 in US FDA (US). For the product to be placed on the EU market, it must bear the CE mark & the product to be placed on the US market, it must be listed with USFDA, which means that the requirements in the EN 14683:2019 standard are also met. There is no obligation to work with a Notified Body in the use of the CE mark for EU & there is no requirement for 510K registration in US. In order for the manufacturer to put the CE mark on its products, they must develop Technical file that meets the requirements of MDD 93/42/EC and this standard & to place in US Market listing in US FDA is necessary. The suitability of its products to the standard should be determined by the experiments given above. If this is achieved, the manufacturer must take the necessary technical and quality control measures to be able to produce continuously with the same performance in mass production. It should prepare a technical file showing that these requirements are met in accordance with the EU legislation and publish the EC Declaration of Conformity & for US FDA listing below steps shall be followed;
Step 1 : Make sure you have DUNS Number.
Step 2 : US Agent Appointment
Step 3 : Establishment Registration
Step 4: Verification of Labels
Step 5: Device Listing

Please contact us in case you wish to draw a DOC on basis technical file as per MDD 93/42/EC or list your device in US FDA or get assistance on testing.

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