With the rapid spread of the new crown pneumonia epidemic, Europe has become a severely affected area. During the epidemic prevention and control, due to the serious shortage of medical supplies such as medical masks and protective coverall, Europe has released a huge demand for protective equipment. European countries have imported a large number of masks, hand sanitizers, protective coveralls, face masks, and other products from China.

Exporting masks, hand sanitizers, protective coverall, and other products from China to the EU market, CE certification is essential. At present, a variety of medical CE certificates appear on the market, and more than 60% are fake and counterfeit CE.

In order to better understand the authenticity of the CE certificate, let’s talk about the specific authentication method. How to let you ensure that masks and other products purchased from Chinese suppliers are truly CE certified by the EU, which can really ensure that the EU consumers are safe to use.

Because we receive a lot of emails every day about how to check and identify, distinguish, mask’ CE authenticity, certificates of other anti-epidemic products. The content of this blog will be Google’s most detailed guide on how to check the authenticity of the CE certificate of the mask when you shipping from China.

Use Bestforworld ’s logistics services to ensure that your medical supplies are safe and reach your destination in a timely manner.

1. Inquiry on the official website of the notified body

Generally, large EU certification and authorization agencies will open a window for querying certificates on the official website. After logging in to the official website of the agency, there will be a page for querying certificates. You can enter the English name, certificate number and other information of the Chinese mask manufacturer to find out if a matching CE certificate appears. If so, then this may be a true certificate.

Of course, this method is only applicable to the situation where the license issuing agency just provides the inquiry service. For institutions that do not open certificate query services, it will not work.

So for this kind of situation, when we get a medical CE certificate, how do we identify whether it is issued by an EU authoritative certification body?

2. Inquiries from EU official websites

We can still try the issuing agency of the certificate of masks or other anti-epidemic supplies provided by the supplier and go to the EU website to check whether it has the EU Medical Device Directive MDD 93/42 / EEC or MDR Medical Device Regulation (EU) 2017/745 Corresponding certification.

1. EU official website MDD 93/42 / EEC medical device directive authorized institutions query address:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13

It can be seen from the official website of the European Union that there are 56 notified bodies authorized by the MDD 93/42 / EEC Medical Device Directive. The list of specific institutions, announcement numbers, and the scope of products that are qualified for review are listed in detail above.

2. From May 26, 2020, the MDR (EU) 2017/745 medical device regulations will formally replace the mandatory implementation of the current MDD medical device directive in the European Union. Also, it can be found on the official website of the European Union. Currently, only the notified bodies with MDR authorization have only 12 homes.

EU official website MDR (EU) 2017/745 Authorities authorized by medical device regulations query address:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

(List of 12 MDR Authorized Institutions)

Therefore, if your medical CE certificate issuing agency is not in the above list, it means that it does not have EU certification for medical products, that is, it cannot issue CE certificates. Then, unfortunately, the CE certificate “is invalid.

In addition, we can also analyze and complete the identification from the CE certification process of medical device products.

Use Bestforworld ’s logistics services to ensure that your medical supplies are safe and reach your destination in a timely manner.

Third, CE certification process analysis and identification

Taking a mask imported from China as an example, first, confirm whether the mask is a medical device. There are two types of masks: medical masks and protective masks. Exports to Europe and the United States must comply with relevant EU regulations:

Personal protective mask:

Regulation is EU2016 / 425 (PPE);

The standard is EN149.

Medical masks:

Regulations are 93/42 / EEC (MDD) or EU2017 / 745 (MDR);

The standard is EN14683.

1. If you import personal protective masks from China, personal protective masks are not medical devices and do not need to meet the requirements of EU medical regulations. You can complete CE certification in accordance with the PPE Personal Protection Directive. The official website of the European Union currently has 112 notified bodies authorized by the PPE Personal Protection Directive Family.

EU Official Website (EU) 2016/425 Authorized Agency for Personal Protective Equipment Inquiry Address:

How to check the authorization of personal protective equipment, please click the following address:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501

2. If you import medical masks from China

For medical masks, certification is required in accordance with medical device regulations. For medical masks, you need to confirm that it is sterile.

If it is a sterile medical mask, it belongs to the category of sterilized medical products in the European Union and must be CE certified in accordance with the Medical Device Directive / Regulation MDD / MDR. In such cases, an authorized notified body must be involved.

If it is a non-sterile medical mask, it is CE self-declared according to the Medical Device Directive / Regulation MDD / MDR. The company does not need to pass the certification of the notified body. After preparing the relevant documents and test reports, it can complete the declaration of conformity.

As far as the current situation is concerned, in view of the difficulty and time required for CE certification of sterile medical masks, most manufacturers have chosen non-sterile medical masks to produce and complete the certification. So when your Chinese mask supplier is established less than one year, or several months, but can provide CE certification for sterile medical masks, it is likely to be a forged certificate.

The point is, since the manufacturer self-declares CE compliance, how can the notified body issue a CE certificate? If CE certificates cannot be issued, what are the so-called certificates that many companies get? Let’s find some templates to see:

Please take a closer look at the contents of the certificate: “Verification of the presence of the Technical Files in regards of the Medical Devices Directive …” This means that this certificate proves that the organization has reviewed the company’s preparation of technical documents in accordance with medical device regulations.

“This document has been issued on a voluntary basis and not as NB …” means that this certificate was issued voluntarily, and it does not mean that I have executed it in the name of the notified body.

“… declares that the only scope of the assessment is to verify the existence of the declaration issued by the manufacturer or an applicant under its own responsibilities” means that this certificate only verifies from their perspective the manufacturer or A statement of compliance issued by the liability exists.

Update May 5, 2020:

In the process of assisting a large number of European importers to operate exports PPE masks and other medical suppliers, Bestforworld emphasizes respecting the laws and regulations of various countries, respecting market laws and trade competition laws.

In accordance with common international trade practices, the quality and safety supervision of imported products is entirely the responsibility of the importing country. The China Customs Announcement No. 5 still put forward clear requirements that the exported medical and anti-epidemic materials should meet the quality standards of the importing countries and regions, which fully reflects China ’s responsibility and responsibility as an exporter of medical materials, Sincere willingness to integrate and deepen international cooperation.

An increasing number of Chinese export enterprises are carrying out certification of foreign capital qualifications. But at the same time, it was also found that some Chinese suppliers were not familiar with the quality standards of the importing country, which caused the export products to fail to complete customs clearance at the destination port, causing unnecessary losses. Medical epidemic prevention materials belong to the category of medical device products, and each country has its own independent quality supervision system and quality standards. For example, EU regulations require that medical device products and personal protective products that enter the EU market must obtain CE certification, and be certified by an authorized announcement agency. Each type of product has corresponding evaluation standards and requirements. Among them, the inspection and certification of products and the internal quality control of enterprises are important contents.

Each type of product has corresponding standard requirements. Even medical masks can be classified as sterile or non-sterile, with different conformity assessment modes. Although personal protective masks are not medical devices, they must comply with the requirements of the European Union’s Personal Protective Equipment Regulations (PPE), and CE certification and certification will be issued by authorized notified bodies. The corresponding standard is EN149. According to the standard, the masks are divided into three categories: FFP1 / FFP2 / FFP3. The official website of the European Union shows that there are 112 notified bodies authorized by the PPE Personal Protection Directive.

Currently, many Chinese suppliers export coronavirus detection reagents to the EU. According to EU regulations, companies should provide a self-declaration of CE conformity, but they must submit a technical document in the EU country for the record through a local European agency.

According to BW’s understanding, many coronavirus kit manufacturers on the market provide simple self-declaration documents without query codes. They are still in the process of filing and in principle have not obtained CE certification. In addition, BW also found that there are currently some unqualified intermediaries that use companies’ lack of understanding of EU regulations to mislead companies to make wrong choices and issue invalid CE certificates, which makes products encounter obstacles when entering the EU market. It caused huge customs clearance troubles for importers….