Mask CE Certification! EU Official Announcement, Policy Interpretation And Certification Qualification
Facing the new crown epidemic situation, To meet the growing demand for masks, protective clothing and other anti epidemic products, the EU has opened a green channel without the need for CE logo to enter the European Union for medical workers. Part of the epidemic prevention materials (such as a class of sterilized medical masks) can be marketed in the EU market even if they are not yet certified by CE.
In March 13, 2020, European Union members released the Official Journal of the EuropeanUnion's recommendations on conformity assessment and market surveillance procedures for medical devices and personal protective equipment (PPE) during the epidemic.
(d) if the market watchdog determines that the product conforms to the basic safety and performance requirements of the medical device, even if its compliance evaluation is not yet completed, the market supervisory authority may allow it to sell within a certain time, and the product must continue to complete its compliance evaluation process.
Personal protective equipment (PPE):
(d) if the product of emergency examination and approval does not adopt the PPE regulations and harmonization standards as other technical requirements for product technical requirements, such as the recommendation requirements of WHO, it is necessary to ensure that the technical requirements adopted are equal to the level of protection of PPE basic health and safety requirements. When announcements are issued to other PPE products that require other technical requirements, the notice authority needs to notify the competent authority and other PPE regulatory notices immediately.
The competent authorities of the member states can also assess and organize the procurement of PPE products without CE marking during the epidemic period, which can only be provided to medical workers and can not be sold in the market. At the same time, spot checks will focus on spot checks of PPE products to prevent serious risks caused by unqualified products.
The key is as follows!!!
Emergency supplies are exclusively for medical staff and can not be circulated in the market.
About CE logo
Today, the CE logo has become a globally recognized quality symbol. The CE logo can prove that the products manufactured or imported to EU member states in conformity with the quality standards meet the requirements of protecting consumers' health, supply chain safety and environmental sustainable development.
Recommended reading by exporting countries : The most detailed history! Official Guide for customs declaration of masks export
| In the European Union, masks belong to PPE personal protective equipment, "hazardous substances and mixtures". Since 2019, the new EU regulation PPE Regulation (EU) 2016/425 has been enforced. All masks exported to the EU must obtain CE certification under the requirements of the new regulations. The CE certificate is valid for about 5 years, and the general cost is 10000-15000 yuan. |
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01, is your company a NB institution? Is the organization number available?
Recently, everyone is worried about the European standard of masks and other medical supplies. Today, Mike has posted the original European Union notices. We can study the specific statements of each standard carefully. Yesterday, after giving the link, many people said that they could not open web pages. In fact, it should be your LAN problem, but it doesn't matter. I'll post it to you:
COMMISSION RECOMMENDATION (EU) 2020/403
Of 13 March 2020
On conformity assessment and market surveillance procedures within the context of context
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European European, to 292,
Whereas:
02
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Ten
Eleven
Twelve
Thirteen
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Seventeen
Eighteen
Article 5 of Directive 93/42/EEC and Article 8 of Regulation (EU) 2017/745 offer, EU, China, China, China, Japan, China, China. Manufacturer choose to adopt such a technical solution, the medical device, the, the, medical, device, the, medical, device, etc. Which is retained ensures that the medical device complies with the with
Article 19 of Regulation (EU) 2016/425 lays down the specific conformity assessment assessment, and it is also known as the ",", ",", "," Which are described respectively in Annexes V, VII and VIII of, and, in, in,
Article 11 of Directive 93/42/EEC and Article 52 of Regulation (EU) 2017/745, once, 2017/745, and, and, and, Should be subjected to the conformity assessment procedure for the EC, EC, conformity
Notified bodies are the conformity assessment bodies designated by Member States Member 26, 4, 7. Notified bodies are required to assess that a PPE product meets product, the first, the second, the third, the third, the third, the third, the right, the right. But also in a situation where the manufacturer has followed other followed situation, in, situation, situation, situation, 2016/425.
Notified bodies should thus assess whether products manufactured in line with line, Such as the ones contained in the WHO recommendations on the on, the first and the second half of the world, the first is the first, the second is the third. Standard or technical solution is compliant with the essential health and, essential, the first and the second, and the other two are the following. The existing channels for exchange of information in the framework of framework 36 channels
In addition, pursuant to the relevant market surveillance procedures in Regulation (EU) pursuant 38 (1) x (2) The market surveillance authorities find that the PPE does not comply, does, and it is also known as the following: Commensurate with the nature of the risk. They shall also inform also, "the first, the second, the third, the third, the third, the right, the right."
Accordingly, to address the shortage of PPE necessary in the context, in, "", " If they are found to be compliant with the essential health health the, the first, the second, the third, the third, the third, the third, the right, the right, the right, the right. "Products can be made available in other Member States and in", "States" and "States", "and". States authorities and to the Commission through the regular market surveillance market
Considering that certain types of PPE or medical devices that are, devices, the first, the second, the second, the second, the second. 8 of the present Recommendation are only made available to healthcare workers,
1., With the objective to ensure availability of PPE and medical devices medical, the first, the second and the third. As well as notified bodies and market surveillance authorities to deploy to, the first, the second, the third, the third, the third, the third, the third, the right, the right, the right. Of health and safety and all relevant stakeholders should ensure that ensure, "Dan," ","
CONFORMITY ASSESSMENT PROCEDURES
3.In the case of PPE products manufactured following technical solutions other, other, PPE, and PPE, Provided that the said technical solutions ensure an adequate level of level, "", "
5.In the case of medical devices, the possibility for Member States Member, case 11, (13)
6.The relevant market surveillance authorities in the Member States should as should, "the first, the second, the third, the third, the third, the right, the right."
8.PPE or medical devices not bearing the CE marking could also could, the first, the second, the third, the third, the third, the third, the third, the right, the right, the right. And made available to other users.
Done at Brussels, 13 March 2020.
Thierry BRETON
Try to change browser or computer: COVID-19 conformity assessment and market surveillance procedures within threat area
The European Commission takes into account the Treaty on the operation of the European Union, in particular its 292nd article, in view of:
2, keeping in mind the health and safety of EU citizens is a top priority. Therefore, it is essential to ensure that the most appropriate personal protective equipment and medical equipment are provided to the most needed people to ensure adequate protection.
4. The requirements for the design, manufacture and marketing of personal protective equipment (EU) 2016/425 promulgated by the European Parliament and the Council in March 9, 2016 (on personal protective equipment) and the abolition of directive No. 89/686 / EEC (1) of the Council.
6. Disposable and reusable respirators can prevent particulate hazards. Disposable and reusable work clothes, gloves and spectacles are used to prevent and prevent harmful biological agents (such as viruses) belonging to products within the scope of this Regulation (EU) 2016/425.
8, in the case of COVID-19 threats, such PPE and medical devices are essential for medical personnel, first aid personnel and other personnel involved in the containment of the virus and to prevent further transmission.
10, the 93/42 / EEC directive and (EU) 2017/745 regulations have fully coordinated the design, manufacturing and sales rules of the medical device alliance market, and have established some basic requirements and general safety and performance requirements according to the following contents. Therefore, the equipment manufactured by the Council Directive 93/42 / EEC and EU (2017/745) can be freely circulated in the entire internal market, and Member States shall not introduce additional and different requirements for the manufacture and market of such equipment.
12, unless specific rules are applied, medical devices related to non-invasive devices belong to category I.
14, according to the eleventh of the instructions 93/42 / EEC and fifty-second of the (EU) 2017/745 regulations, once the latter is applicable, the manufacturer shall carry out the applicable conformity assessment procedures in order to put the medical devices on the market, and if the appropriate procedures prove that they meet the applicable basic requirements or general safety and performance requirements, please affix the CE logo. Member states may, on due grounds, require approval to be deroged from the conformity assessment procedure so as to put the market in the territory of the member states concerned and to protect the health of the protected individual equipment in use.
16, 93/42 / EEC directive and regulation (EU) 2017/745 is technically neutral and does not prescribe any specific mandatory technical solution for the design of medical equipment. Conversely, the appendix I of directive 93/42 / EEC has set up the basic requirements. The annex I of regulation (EU) 2017/745 sets general safety and performance requirements, and medical equipment should meet these requirements before placing them in the market and free circulation throughout the EU market.
18, the eighth of the fifth and regulation (EU) 2017/745 of the directive 93/42 / EEC provide manufacturers with the possibility of relying on specific technical solutions. These solutions are detailed in the unified standard or part of it, whose references are in the official European Union magazine. According to this section, if the manufacturer chooses to adopt such a technical solution, it is assumed that medical devices meet the above coordination standards or the requirements covered by them. However, it is not necessary to comply with the standards of coordination. Manufacturers are free to choose other technical solutions, provided that specific solutions are retained to ensure that the medical equipment meets the applicable basic health and safety requirements.
20. When the fifty-second of 93/42 / EEC directive eleventh and EU (2017/745) are applied, a specific conformity assessment procedure for different types of medical equipment will be worked out. Under these terms, medical equipment belonging to category 1 (except for customized or research equipment) shall be subject to conformity assessment procedures of EC conformity declaration without the participation of third party conformity assessment bodies.
22, therefore, the announcements should assess whether the products produced by other technical solutions (e.g., the products contained in the recommendations of the who on the choice of personal protective equipment) are also in line with the applicable basic health and safety requirements. Taking into account the importance of ensuring the effective exchange of information among all stakeholders in the personal protective equipment supply chain, the announcements concluded that personal protective equipment that complies with another specific standard or technical solution meets the basic health and safety requirements applicable to them, which will help to rapidly assess the production of solutions based on the same standard or technical solution. Other products. For this reason,
24, therefore, in order to solve the problem of PPE shortage when COVID-19 breaks out (the non CE mark PPE intends to enter the EU market), the relevant market supervisory bodies should evaluate the products. If these products are found to meet the requirements of the basic health and safety requirements stipulated in the relevant regulations, they should take measures to make them within a limited time or in conjunction with the designated institutions. At the same time, this kind of PPE is put into the EU market. In order to ensure that such products can be provided in other Member States and take into account the importance of ensuring effective exchange of information and coordinating responses to all threats to the health and safety of citizens,
The proposal was adopted:
Conformity assessment procedures
Market supervision procedures
6, the relevant market supervisory bodies of Member States should give priority to the attention of non-compliance personal protective equipment or medical equipment, which will pose serious risks to the health and safety of their prospective users.
7, the market watchdog found that PPE or medical equipment could ensure adequate health and safety level according to the basic requirements of (EU) 2016/425 regulations, 93/42 / EEC directive or 2017 (EU) regulations. 745, even if the conformity assessment procedures, including the CE logo, have not been fully completed in accordance with the coordination rules, they can still authorize the implementation of these product procedures in the EU market at a limited time.
8, PPE or medical devices without CE signs can also be assessed and part of the purchase is organized by the authorities of the relevant member countries, provided that the products are available to medical staff only during the current health crisis and that they are not used in conventional distribution channels and can be used by other users.
9, the market supervisory authority shall immediately inform the Committee and other member states of any interim arrangements it has granted to specific PPE or medical equipment. For personal protective equipment, the information and communication system (ICSMS) used for market surveillance should be completed.
Annex: list of EU Member States (27 countries):
Austria, Belgium, Bulgaria, Cyprus, Czech, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Romania, Lithuania, Luxemburg, Malta, Malta, Malta, Portugal, Belgium, Spain, Sweden.
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