With the rapid spread of the new coronavirus pneumonia epidemic, Europe has become the hardest hit area. In the process of epidemic prevention and control, due to the serious shortage of medical masks, protective clothing and other medical supplies, Europe has released huge external demand for protective supplies.
CE certification is essential for exporting to the EU market. There are currently a variety of medical CE certificates on the market, which is dazzling. In order to better let everyone understand the authenticity of the CE certificate, let’s talk about the specific identification methods below.
1. Inquiry on the official website of the notified body
Generally large EU certifications Authorized organizations will open a certificate query window on their official website. After logging in to the organization’s official website, there will be a certificate query page. You can enter the manufacturer’s English name, certificate number and other information to check whether a matching CE certificate appears. If so, it’s probably a genuine certificate.
Of course, this method is only applicable when the issuing agency happens to provide inquiry services. It will not work for unopened certificate query service organizations.
So in this case, when we get a medical CE certificate, how can we identify whether it is issued by an authoritative EU certification agency?
2. EU official website agency query
We can still try to Start with the issuing agency of the certificate in your hand and check on the EU official website to see if it has the corresponding certification qualifications of the EU Medical Device Directive MDD93/42/EEC or the MDR Medical Device Regulation (EU) 2017/745.
1. EU official website MDD93/42/EEC Medical Device Directive authorized agency inquiry address: https://ec.europa.eu/growth/tools-databases/ nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
(List of 56 MDD authorized bodies)
As can be seen from the EU official website, there are 56 notified bodies authorized by the MDD93/42/EEC Medical Device Directive. The specific list of institutions, announcement numbers, and the scope of products qualified for review are listed in detail above.
2. Starting from May 26, 2020, the MDR (EU) 2017/745 Medical Device Regulations will officially replace the EU’s current MDD Medical Device Directive. It can also be found on the EU official website that there are currently only 12 notified bodies with MDR authorization.
European Union official website MDR (EU) 2017/745 Medical Device Regulations authorized agency inquiry address: https://ec.europa.eu/growth/tools-databases/ nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
(List of 12 MDR authorized institutions)
So if you have If the medical CE certificate issuance agency is not included in the above list, it means that it does not have the EU certification qualification for medical products, let alone the issuance of CE certificates. Then I regret to say that the “CE certificate” you got is Invalid.
In addition, we can also start from the CE certification process of medical device products to analyze and complete the identification.
3. Process analysis and identification of CE certification
Using masks as the For example, first confirm whether the mask is a medical device. Masks are divided into two types: medical masks and protective masks. Exports to Europe and the United States must comply with relevant EU regulations:
Personal protective masks: The regulation is EU2016/425 (PPE); standard It is EN149.
Medical masks: The regulation is 93/42/EEC (MDD) or EU2017/745 (MDR); the standard is EN14683.
1. Personal protective masks Personal protective masks are not medical devices and do not need to meet the requirements of EU medical regulations. They only need to complete CE certification in accordance with the PPE personal protection directive. EU official website There are currently 112 notified bodies authorized by the PPE Personal Protection Directive.
European Union official website (EU) 2016/425 Personal protective equipment authorized agency inquiry address: https://ec.europa.eu/growth/tools-databases/nando /index.cfm?fuseaction=directive.notifiedbody&dir_id=155501
(List of 112 PPE authorized agencies)
CE certificate identification (PPE):
(Source: CCQS certification)
2. Medical masks
If it is a medical mask, it needs to be certified according to medical device regulations. For medical masks, it is necessary to further confirm whether it is sterile.
If it is a sterile medical mask, it is a type of sterilized medical product in the EU and must be CE certified in accordance with the Medical Device Directive/Regulations MDD/MDR. In this case, an authorized notified body must be required attended.
If it is a non-sterile medical mask, it will make CE self-declaration in accordance with the Medical Device Directive/Regulations MDD/MDR. The company does not need to be certified by a notified body. When it is ready After receiving the corresponding documents, test reports and other information, you can complete the declaration of conformity by yourself.
As far as the current situation is concerned, given that the CE certification of sterile medical masks is difficult and takes a long time, most manufacturers have Select non-sterile medical masks to produce and complete certification.
An important point needs to be drawn here. Since the manufacturer self-declares CE compliance, how can a notified body issue a CE certificate? If CE certificates cannot be issued, then what are the so-called certificates that many companies have obtained? Let’s find some templates to look at:
Please carefully study the content of the certificate: “Verification of the presence of the Technical Files in regards of the Medical Devices Directive…” means that this certificate proves that the organization has reviewed that the company has complied with the requirements of medical device regulations to prepare technical documentation.
“This document has been issued on voluntary basis and not as NB…” means that this certificate is issued on a voluntary basis and does not mean that I am executing this in the name of a notified body. thing.
“…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 this certificate They only verify from their perspective that the declaration of conformity issued by the manufacturer or applicant under their own responsibility exists.
Therefore, this type of so-called certificate is not a true CE certificate issued by an authorized notifying body. Please be sure to keep your eyes open to identify the authenticity.
