Crack down on counterfeits! The European Union issued a notice of suspicious CE certificates! CE Certification May Be Ch
Crack down on counterfeits! The European Union issued a notice of suspicious CE certificates! CE Certification May Be Ch
Relevant enterprises have also made explanations when exporting. Non-medical masks should not be used for medical purposes, nor should they be used by health care workers working in intensive care units. Liu Changyu said that the Chinese government has always attached great importance to the quality and safety of medical materials and implemented strict management of related products. During the special period of epidemic prevention and control, in order to further strengthen the supervision of the export quality of medical materials and standardize the export order, the Ministry of Commerce, together with the General Administration of Customs and the Food and Drug Administration, issued a notice that the export of relevant medical products must obtain the registration certificate of medical devices in China and meet the quality standards of importing countries (regions). Liu Changyu also stressed: "We hope that foreign purchasers will choose product suppliers registered with China's drug regulatory authorities, carry out corresponding quality inspection before using the products, and use them correctly in strict accordance with the scope of application and operating procedures of the products.". If there are relevant problems in procurement and use, it is suggested that the enterprises of both sides should properly negotiate and solve them according to the principle of commercialization. EU Issues Notice of Suspicious CE Certificates on PPE Notice Recently, the European Safety Federation published an article on its official website saying that they had learned from different sources that "certificates" were used as the basis for CE marking of PPE (including FFP2/FFP3 masks), and that these "certificates" had no legal value and could not be used as the conclusion of conformity assessment. So far, "certificates" have been seen on the letterheads of CELAB, ICR Polska, ISET, ECM, NPS, CIC, Amtre Veritas and GTS, and it is not clear whether these documents were actually issued by the aforementioned organizations. Here are some examples from different agencies: ICR Polska, 2 cases CELAB, 2 cases ISET, 1 case (already mentioned as false on ISET's website) ECM, 1 case (the CE marking of the respirator has the identification number of the notified body ECM next to it, but the ECM is not the notified body for personal protective equipment, so the CE marking is invalid) NPC, 1 case CIC, 1 case Amtre Veritas, 1 case GTS, 1 case (file title is self-declaration) ICR Polska, 2 cases CELAB, 2 cases ISET, 1 case (already mentioned as false on ISET's website) ECM, 1 case (the CE marking of the respirator has the identification number of the notified body ECM next to it, but the ECM is not the notified body for personal protective equipment, so the CE marking is invalid) NPC,Against Bacteria Breathable KN95 Face Mask, 1 case CIC, 1 case Amtre Veritas, 1 case For details and specific pictures of the above cases, please refer to the case link under the official website of the European Security Union. https://www.eu-esf.org/covid-19/4513-co ... es-for-ppe The European Security Association said that although the top priority is to bring as many masks (and other related personal protective equipment) into the EU as possible in order to protect health care workers. However, it is unacceptable that masks that do not provide the claimed, sub-standard protection are provided to health care workers who are now at high risk. Protective masks (e.g. FFP2/FFP3) are Class III PPE according to Regulation (EU) No 2016/425. This means that conformity assessment includes: 1. The "EU Type Examination Certificate" (Module B Certificate for short) will be issued after the type examination conducted by the Notified Body is qualified. 2. Production tracking or random inspection or system audit conducted by the notified body, referred to as Module D certificate or Module C2 certificate.
Therefore, at present, only notified bodies authorized by the European Union (EU) 2016/425 PPE Regulation for mask products Module B, Module C2 and/or Module D have the right to engage in CE certification of PPE personal protective masks. In view of the shortage of PPE resources and the health crisis during the outbreak, the European Commission published Recommendation (EU) 2020/403 on Conformity Assessment and Market Surveillance, which allows Member States to put PPE on the market where the conformity assessment process has not yet been fully completed. This only applies if purchased by a health care authority during a crisis, but this does not mean that the product does not have to comply with the applicable essential health and safety requirements set out in the PPE Regulation, and PPE entering the normal chain of distribution must still be fully compliant. The European Security Union reminds all interested parties to check that the PPE "certificates" you receive are correctly named "EU type examination certificate" and that they have been issued by a qualified Notified Body. The Notified Body's identification number must be included in the certificate. How to identify "misleading" or "fake" certificates In any case, look for the wording "EU type examination certificate" (or exactly the same wording in another EU language-check the national version of the legislation for the correct legal terminology). Names such as' verification of compliance ',' certificate ',' certification report 'are not correct legal terms and therefore documents with such names are not valid EU type examination certificates. If the address of the "notified body" mentioned above is outside the EU, this is already a strong indication that there is a problem with the document, as the notified bodies for PPE are all located in EU member States or in some countries with mutual recognition agreements. Also look for the Notified Body's name and number (4-digit number). To ensure that the notified body is indeed genuine and qualified, you can check the Nando database to identify it. In any case, look for the wording "EU type examination certificate" (or exactly the same wording in another EU language-check the national version of the legislation for the correct legal terminology). Names such as' verification of compliance ',' certificate ',' certification report 'are not correct legal terms and therefore documents with such names are not valid EU type examination certificates. If the address of the "notified body" mentioned above is outside the EU, this is already a strong indication that there is a problem with the document,Medical Full Body Coverall, as the notified bodies for PPE are all located in EU member States or in some countries with mutual recognition agreements. Also look for the Notified Body's name and number (4-digit number). To ensure that the notified body is indeed genuine and qualified, you can check the Nando database to identify it. The official website of the European Security Association will regularly update the cases of suspicious PPE certificates, and the details can be found in the https://www.eu-esf.org/covid-19/4513-co ... es-for-ppe. Appendix 1: EU CE Certification for Export or MDR (FYI) (Slide to view) Export EU CE certification may be changed to MDR After the outbreak of COVID-19, masks, as a necessity for epidemic prevention and control, have changed from supplies used in specific fields to daily necessities that are hard to find in reality.
As the world's factory, China has also flocked to thousands of mask manufacturers overnight. Quite a number of these mask companies aim at the EU region where the epidemic is serious, hoping to put their masks into the EU market, and the basic certification requirement of the EU market is CE certification, which is the "passport" to open and enter the European market, and is the mandatory requirement of EU law for restricted products. At present, the newly completed CE certificates for medical masks on the market are basically issued based on the EU Medical Device Directive MDD 93/42/EEC. However, there is a potential crisis: the CE certificate of some masks on the market may be changed in more than a month. Analysis of MDR (EU 2017/745) On May 5, 2017, the European Union issued a new version of the Medical Device Regulation MDR (EU 2017/745). On May 25, 2017, the MDR came into effect. The transition period between the old MDD (93/42/EEC) and the new MDR (EU 2017/745) is three years. That is to say, from May 26, 2020, the MDR Directive will be enforced in the European Union, which will completely replace the old Medical Device Directive MDD (93/42/EEC) and the old Active Implant Medical Device Directive AIMDD (90/385/EEC). However, for products that have been officially launched in the EU channel, the old MDD directive CE certificate can be maintained until May 26, 2024; It should be pointed out in particular that After the MDR is enforced, the newly applied CE certification must be executed in accordance with the MDR; Products without CE certificate at present must be certified according to MDR from May 27; MDD certificates issued before May 26, 2020 can still be used within the validity period, up to May 26, 2024; The original MDD certificate shall be replaced with an MDR before the certificate becomes invalid. The specific transition schedule of the EU CE Medical Directive is shown in the figure below: What impact will the EU MDR directive, which came into effect on May 26, have on the current CE certification of medical masks? 1. Acquired during the outbreak of COVID-19 CE certified medical masks, it can be said that more than 95% of them are carried out in accordance with the old MDD directives, and may face the problem of renewing the new version; 2. According to the latest EU statistics, ? There are 56 NB Notified Bodies with MDD (93/42/EEC) authorizations for the old Directive, while there are currently only 12 NB Notified Bodies with MDR authorizations. That is to say, from May 26, 2020, the choice of CE certification audit institutions for medical masks has been reduced by 80%; 3. Due to the European Union The reduction of the options of such authorized review bodies as MDR (NB: Notified Body) will inevitably lead to a considerable probability that the cost of CE certification for medical masks will be greatly increased; 4. New edition MDR directive audit requirements are more complex than the old version of the MDD directive, the certification cycle is bound to be greatly extended, during the epidemic, some agencies claimed that the possibility of a few days of certification will be basically zero; 5. Get Medical equipment such as masks certified by CE must be required to have a designated authorized representative of the European Union (referred to as "European generation"), which was not strictly regulated by the European generation for some low-risk products in the previous MDD directive, but after the MDR directive, even medical products sold on some e-commerce platforms will be required to provide the necessary European generation information; 6. The system audit process and requirements of MDR are more complex and cumbersome. For example, in Article 15 of MDR, medical device manufacturers should have at least one person responsible for regulatory compliance within their organizational structure. Person responsible for regulatory compliance.
The personnel shall have the necessary professional knowledge in the field of medical devices and have a series of qualification requirements (such as law, medicine, pharmacy, CE Certificate KN95 Mask ,KN95 Mask for Epidemic Prevention and Control, engineering or other related disciplines, and at least one year of professional experience related to medical device regulatory affairs or quality management system); 7. For products that have been officially launched in the EU channel ? The old MDD directive CE certificate can be maintained until May 26, 2024. However, if the enterprise products are not sold in the EU market before May 26 this year, in principle, the old MDD certificate should be re-applied for adjustment to the MDR version after May 26 this year. This time, the EU issued Regulation directly, which is different from the previous Directive in that it has increased its binding force and issued a binding law that immediately enters into force in EU member States. This Regulation does not need to be translated into local laws and regulations by member countries to implement as Directive. Therefore, when applying for CE certification of medical products, enterprises should carefully consider whether to choose the latest regulations or the old directive scheme in the transitional stage, and also need to understand and confirm the certification qualification of NB institutions to ensure the continuity of product sales in the EU market. Attachment ①: From May 26, 2020 List of 12 MDR authorized institutions Attachment ②: Before May 26, 2020 List of 56 MDD authorized institutions Affected by the epidemic, the policies of many countries and institutions are changing frequently, such as the attitude of the United States towards the Chinese standard KN95 masks. Therefore, it is still unknown whether the MDR directive will be implemented or whether it will be postponed. We can only wait and see what happens! Appendix 2: EU CE Qualification Certification Guidelines and US FDA Certification Emergency Authorization (Slide to view) EU CE Qualification Guidelines Exporting to the EU market, CE certification is essential. At present, there are all kinds of medical CE certificates on the market, which make people dazzled. In various industry Wechat groups, it is often seen that someone has issued a so-called CE certificate, asking you to help distinguish the true from the false. In order to help you better, let's talk about the specific identification methods. There are many ways to check the authenticity of CE certificates, first of all, the most simple and crude one. Large notified bodies will open a window on their own official website to inquire about certificates. Of course, this method is only applicable to the situation where the issuing authority just provides inquiry services. For organizations that do not open certificate inquiry services, it will not work. So for this kind of situation, when we get a medical CE certificate, how can we identify it? We can still try to start with the issuing agency of this certificate in your hand and go to the official website of the European Union to check whether it has the corresponding certification qualification of the European Union Medical Device Directive MDD 93/42/EEC or MDR Medical Device Regulation (EU) 2017/745 and Personal Protective Equipment Authorization (EU) 2016/425.
The inquiry address of the organization authorized by MDD 93/42/EEC Medical Device Directive on the official website of the European Union: https://ec.europa.eu/growth/tools-datab ... &dir_id=13 The inquiry address of the organization authorized by MDR (EU) 2017/745 Medical Device Regulation on the official website of the European Union: https://ec.europa.eu/growth/tools-datab ... &dir_id=34 European Union Official Website (EU) 2016/425 Personal Protective Equipment Authorized Agency Enquiry Address: https://ec.europa.eu/growth/tools-datab ... r_id=15550 As can be seen from the official website of the European Union, there are 56 notified bodies authorized by the MDD 93/42/EEC Medical Device Directive. The specific list of notified bodies, the notification number, and the scope of products with qualifications are listed in detail. Since May 26, 2020, MDR (EU) 2017/745 Medical Device Regulation will formally replace the current MDD Medical Device Directive of the European Union. It can also be found on the official website of the European Union that there are only 12 notified bodies with MDR authorization. Therefore, if the medical CE certificate issuing agency in your hand 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, unfortunately, the "CE certificate" you got is invalid. In addition, we can also start from the process of CE certification of medical device products to analyze and complete the identification. Take the mask as an example, first of all, confirm whether the mask is a medical device. Masks are divided into medical masks and protective masks. If it is the latter, it is not a medical device and does not need to meet the requirements of EU medical regulations. CE certification can be completed in accordance with the PPE Personal Protection Directive. If it is a medical mask, it needs to complete the certification according to the medical device regulations. For medical masks, it is necessary to further confirm whether they are sterile. If it is a sterile medical mask, which belongs to a class of medical products with sterilization in the European Union, it must be certified by CE in accordance with the Medical Device Directive/Regulation MDD/MDR. In this case, an authorized notified body must be involved. If it is a non-sterile medical mask, it is a CE self-declaration in accordance with the Medical Device Directive/Regulation MDD/MDR. The enterprise does not need to pass the notified body certification. After preparing the corresponding documents and test reports, it can complete the declaration of conformity by itself. As far as the current situation is concerned, in view of the difficulty and long time required for CE certification of sterile medical masks, most manufacturers have chosen non-sterile medical masks to produce and complete the certification.
Here we need to draw a key point, since it is the manufacturer's self-declaration of CE conformity, how can the notified body issue the CE certificate? If the CE certificate can not be issued, what is the so-called certificate that many enterprises get? Let's take a look at some templates: Please study its content carefully: "Verification of the presence of the Technical Files in regards of the Medical Devices Directive …" This certificate certifies that the organization has reviewed that the facility has prepared the technical documentation in accordance with the requirements of the Medical Device Regulation. Again: "This document has been issued on voluntary basis and not as NB …" It means that this certificate is issued voluntarily and 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 the certificate merely verifies, from their point of view, that a declaration of conformity issued by the manufacturer or applicant under its own responsibilities exists. Therefore, this kind of so-called certificate is not a CE certificate issued by an authorized notified body in the true sense. So please be sure to keep your eyes open to identify the authenticity. US FDA Certification Emergency Authorization The management of medical devices in the United States is centralized in the Center for Devices and Radiation Health (CDRH) of the Food and Drug Administration (FDA). Medical masks, thermometers (including ear thermometers, forehead thermometers, general electronic thermometers and mercury thermometers) and protective suit and isolation suits used under medium to high risk are Class II medical devices, which need to apply for 510 (K). Although N95 mask can be exempted from 510 (K), they must first obtain N95 certification from NIOSH of CDC. FDA has only prescription and non-prescription for all medical devices, and there is no difference between home use and professional use. The 510 (K) application process is as follows: Usually, it takes 8-10 months for a product to start 510 (K), prepare for testing and various documents until the final review is completed, and the time for first-time applicants is usually longer. In addition to 510 (K), FDA requires all medical device companies to conduct Establishment Registration and Product Listing, which is no exception for products authorized for emergency use. For all overseas enterprises, the Dun and Bradstreet code should be obtained before registration. The code is issued by Huaxia Dun and Bradstreet Company in China. The free code can be obtained in about 30 days. After obtaining the Dun and Bradstreet code, it will take about 1-2 weeks to complete the site registration and product listing. FDA will not issue any certificate to a facility, whether it is a 510 (K), site registration, or product listing, based solely on the data in the U.S. FDA database. That is to say, all kinds of certificates with eagle marks that you have seen have no validity. At present, the novel coronavirus epidemic in the United States has shown a clear trend of outbreak, and all kinds of medical supplies are also becoming tense.
The US Food and Drug Administration (FDA) began to investigate the potential shortage of medical devices in early February this year (2020), and issued various emergency use authorizations (Emergency Use Authorization, EUA) in response to the shortage of various medical devices. At present, the products that can apply for EUA are mainly N95 mask that have not been marketed, new coronavirus diagnostic reagents that have not been marketed, alcohol-based hand rub products that have not be marketed, non-invasive remote monitoring systems that have been marketed but need to be expanded, and respiratory devices that have been marketed and not marketed. COVID-19 detection reagents: Diagnostic reagents are the first to go, and the FDA has released the second edition of the guidelines for this product. The first edition of the guidelines focused on EUA applications for tests developed by clinical laboratories in the United States, while the second edition included detailed guidance for manufacturers to submit EUA applications. The content of EUA application is similar to that of 510 (K), including the description of test reagent, intended use, performance evaluation report, clinical evaluation protocol, stability test protocol, label identification, etc. Because it is an emergency approval, the FDA also requires companies to provide Fact Sheets for patients and professionals. At present, Haihe Consulting has completed the EUA application for the colloidal gold method of the novel coronavirus detection kit. Masks: The second shortage is masks. There are many types of masks in the United States, and Haihe has also held special online seminars on the registration channels of masks, explaining the listing channels of different types. FDA has also issued two rounds of EUA notifications for masks. The first round of EUA allows the direct use of masks that meet the following conditions: (1) All single-use filtering respirator respirators (including N95 mask) that are approved as non-powered air purifying filtering facepiece respirators under NIOSH 42 CFR part 84. And (2) NIOSH approved filter face masks that have passed the manufacturer's recommended shelf life for use by health care workers in a medical setting to prevent exposure to pathogenic airborne particles due to a shortage of face masks. Considering that such measures are still unable to guarantee the supply of masks in the U.S. market, FDA recently issued an EUA application for masks. In particular, masks that have not been approved by NIOSH can also be applied for EUA, but they must comply with: Condition 1-Meet country-specific performance standards, including Australia: P2, P3 Brazil: PFF2, PFF3 EU: FFP2, FFP3 Japan: DS/DL3, DS/DL2 Korea: Special 1st Mexico: N100, P100, R100, N99, P99, R99, N95, P95, R95 And/or Condition 2-Country Specific Marketing Authorisation, including: EU: CE certification; Australia: ARTG Registration Canada: Certificate of Registration; Japan: Medical Device Registration Certificate. Non-invasive telemonitoring systems: such as wearable devices, handheld devices, or home stationary monitoring devices. Product categories include thermometers, electrocardiographs, ECG software, oximeters, sphygmomanometers, respiratory monitoring equipment, etc. These monitoring devices should have potential network connectivity capabilities, including Bluetooth, Wi-Fi or cellular networks, and be able to transmit test data directly to medical institutions. In response to the COVID-19 epidemic, the FDA will allow limited changes in indications, claimed functions, hardware or software for non-invasive remote monitoring systems that have been approved by the FDA for marketing during emergency use, without the need to submit 510 (K) applications for changes. Respiratory equipment: respiratory equipment applicable to emergency use authorization refers to the equipment that provides ventilation and respiratory support for patients with respiratory failure or respiratory insufficiency, including but not limited to hospital continuous ventilator, home continuous ventilator, emergency ventilator, etc.
FDA still recommends that medical institutions use FDA-approved conventional/fully functional ventilators, but considering the availability of as much as possible, FDA will allow limited changes in indications, declared functions, hardware or software of respiratory devices that have been approved by FDA for marketing during emergency use. There is no need to file a 510 (K) application for the change. In addition, FDA has opened an EUA application for respiratory devices. For manufacturers interested in applying, FDA will intervene in advance to communicate with manufacturers about the requirements of relevant application documents and conduct an expedited review of relevant applications. Alcohol-based hand rub products: Previously, alcohol-based hand rub products were regulated as over-the-counter drugs in the United States, while alcohol in hand sanitizers was regulated as API. Currently, the FDA has issued a notice that it will not take action against manufacturers of alcohol used in hand sanitizers or manufacturers of hand sanitizers,KN95 Mask with Fast Shipping, that is, it can be assumed that the FDA will allow the direct sale of alcohol and alcohol-based hand sanitizer in the United States under certain restrictions. Haihe Consulting Special Reminder: The manufacturers of hand sanitizers are limited to pharmacists and federal facilities, not to other commercial manufacturers. (Source: Shiyun.com) Return to Sohu to see more Responsible Editor:. zjyuan-group.com