Medical supplies masks exported to the European market for CE marking?
The European market for the management of masks is divided into two main categories, personal protective masks and medical masks. Personal protective masks are mainly industrial protection, medical masks are mainly hospital use.
Medical masks
Medical masks correspond to the European standard EN14683, the standard for the classification of masks as shown in the figure below, according to the BFE, breathing impedance and splash-proof ability is divided into three categories.
According to the requirements of the medical device regulation 2017/745/EU, mask products can be managed according to a class of devices. Depending on whether the product is supplied in a sterile or non-sterile state, the certification model is different.
From the current overall situation, if you have not obtained the CE certificate from the notified body, there is no possibility to apply for it temporarily, so the mask products exported to Europe should only be provided in a non-sterile state as an option. However, non-sterile is not a complete lack of control of the production environment, EN14683 for the initial contamination of the product bacteria requirements are not greater than 30cfu/g.
Two protective masks
Protective masks of the European standard is EN149, according to the standard will be divided into three categories of masks FFP1/FFP2 and FFP3.
Protective masks need to meet the requirements of the EU Personal Protective Equipment Directive (PPE), protective masks belong to the complex design of the product. Exported to Europe need to be authorized by the announcement of the agency to certify and issue certificates, the certification of the information needed include:
Exported to the U.S. market on the FDA certification
The U.S. regulations on the medical masks and industrial protective masks is the same distinction between the management of the medical masks by the FDA, while the protective masks are controlled by the NIOSH. The familiar N95 mask comes from a category of NIOSH masks.
A) Medical masks
The United States for medical masks is the governing body of the FDA, in the FDA system for the classification of masks have the following three codes. One is for surgical masks, one for pediatric masks, and one for surgical masks with antimicrobial/antiviral media.
The three categories of masks all fall under Rule 878.4040, the classification is Class II, and all require a 510K approval. So the pathway we must take for normal export of masks to the U.S.
But the process takes at least six months. So are there other options available?
1. N95 masks that are already NIOSH-approved can be registered directly
If your N95 mask is NIOSH-approved and passes biological, flame retardant, and blood penetration tests, then you are exempt from the 510K and can go directly to factory registration and device listing.
2.? Obtain authorization from the manufacturer holding the 510K to act as its foundry to use its 510K approval number for corporate registration and device listing. The applicant will need to obtain a letter of authorization and will need to sign a formal quality agreement, which will be verified and spot-checked by the FDA. The use of an unauthorized number will result in the risk of a product recall.
II) Protective Masks
NIOSH divides masks into nine categories, N95, N99, N100, R95, R99, R100, P95, P99, and P100 combined. In a sense, N95 is one of the lower protection categories, and NIOSH's mask protection level certification process is complex.
Other protective gear exported to the U.S. should be FDA-registered?
Isolation suits, gowns, surgical gowns, and other protective products exported to the U.S. need to be registered with the FDA, and some may need to do the FDA 510K declaration.