What is Non-sterile mask CE certification and FDA certificate

For many products, CE certification is a necessary certificate to enter the European market and FDA certificate is important to import US. The most popular CE certification category recently is masks, and many new mask manufacturers are actively applying for the CE certification in response to demand from European buyers. However, recent CE certificates issued by various organizations make it difficult to distinguish and use them correctly, and ShipShipShake hopes that the analysis in this article will give you a clear understanding of this.

Overview of European regulations on mask control

Just as the control of masks in China is divided into medical and civil types, the control of masks in Europe is also divided into the following two types:

  1. Surgical masks need to meet the requirements of the medical device directive (93/42/EEC, to be replaced by (EU) 2017/745 on 26 May 2020). Surgical masks are classified as category I devices according to the European classification rules for medical devices, which are also classified as bacteria-free and non-bacteria-free. Since European regulations are in the transition period, it is almost impossible for new companies to apply for bacteria-free surgical masks in a short time.
  2. For civil masks, the requirements of the personal protection directive (EU) 2016/425 should be met. Mask application for PPE certification requires a CE certificate issued by a public body qualified for the corresponding product range to meet European requirements. This article will not focus on the certification of civilian masks.
European compliance path for all types of masks
European compliance path for all types of masks

As can be seen from the above, for the production of surgical masks enterprises, the only choice to quickly get access to the EU market access, non-sterile masks.

Part 2
Eu guidelines on market access for category I medical devices

There is a wide range of opinions on how to do CE certification for non-sterile masks. We should follow the official guidelines of the European Union. The following is the latest official eu guidance document published in December 2019, entitled “category I medical device manufacturers’ guide”.

As a manufacturer of non-sterile disposable surgical masks, how to legally sell their products to the eu market, we can clearly understand the relevant path by looking at the directory file of the guide, as shown in the following figure:

Note: paragraph d of article 3 only applies to class I* (sterilization, measuring function, reuse) instruments. Therefore, for manufacturers of non-sterile disposable surgical masks, if they need to comply with the eu medical device regulations, they need to meet the following requirements:

  1. The quality management procedures reflect the requirements of MDR (meeting the above clause 0);
  2. Preparation of MDR technical documentation (a/b/c/e, art. 4, 5, 6 and 8, subject to article 3 above);
  3. Appoint an authorized representative of the eu to complete the European registration (subject to article 7 above).

Therefore, compliance with eu MDR regulations depends on whether you:

  1. A complete set of technical documents in compliance with eu regulations;
  2. Whether an authorized representative of the eu has been appointed;
  3. Whether the registration of the competent European authorities has been completed.

Part 3
What does the compliance review of European buyers focus on

Recently, we have obtained many emails of inquiry and verification information from European purchasers, from which we can see that their compliance review focuses on the following aspects:

  1. Whether the authorized representative of the eu is appointed;
  2. Compliance with the requirements of the directive, including signing DOC, providing technical documents and completing registration;
  3. Whether the product testing has been completed;
  4. Whether the difference between sterile and non-sterile products is accurately distinguished;
  5. Accuracy of labels.

Part 4
Why is FDA certificate

The Food and Drug Administration (FDA) is one of the executive agencies set up by the U.S. government at the department of health and human services (DHHS) and the department of public health (PHS). As a scientific regulatory agency, the FDA is responsible for ensuring the safety of food, cosmetics, drugs, biologics, medical equipment, and radiological products produced or imported in the United States. It was one of the first federal agencies whose primary function was consumer protection.

Part 5
Classification of masks and protective indicators

Masks are divided into two categories: respirators and surgical masks, which can be referred to as respirators and surgical masks. The protective indicators of surgical masks generally include the following aspects:

  • bacterial filtration efficiency (BFE) : The larger the value, the better, represents the ability to block bacteria; Bacteria are generally 0.2-2 microns in diameter
  • particle filtration efficiency (PFE) : The larger the value, the better, represents the blocking capacity of micro particles; Here, the diameter of the microparticle is generally lower than the diameter of the bacteria particles; Therefore, if the particle filtration efficiency is high, the bacterial filtration efficiency must be high
  • synthetic blood penetration resistance: The higher the value, the better, represents the resistance to liquid spillage
  • pressure difference: The higher the value, the better, represents the pressure difference between inside and outside the mask. The higher the pressure difference, the better the sealing, and the higher the protection ability.

Part 6
U. S. standards and grades of masks

The American standard for respirators is: BNOISH/national institute for occupational safety and health.
The protection level should be noted as follows:

N95: PFE >= 95%
N99: PFE >= 99%
N100: PFE >= 99%

The standard for surgical masks in the United States is ASTM F2100

The protection level should be noted as follows:

Level 1 (BFE > 95%, PFE >= 95% @0.1 micron, pressure difference < 4.0, liquid resistance =80 mmHg)
Level 2 (BFE> 98%, PFE >= 98% @0.1 micron, pressure difference < 5.0, liquid resistance =120 mmHg)
Level 3 (BFE > 98%, PFE >= 98% @0.1 micron, pressure difference <5.0, liquid resistance =160 mmHg)

We believe this article will help you understand better about CE and FDA certificate and please purchase masks from the regular channels.