3月20日、欧州連合は指令を出しました。 新しいクラウンの流行に直面して、マスク、 、一部の流行防止材料（滅菌済み医療用マスクのクラスなど）は安全性と有効性を満たすことが許可されています。 CE認証を取得しておらず、EU市場でも販売可能です。
93/42 / EEC医療機器指令は、次の2つの広い領域をカバーしています。
The following are specific descriptions of the two major aspects:
01: MDD for medical devices
If the market surveillance agency determines that the product meets the basic safety and performance requirements of the medical device, even if its compliance evaluation has not been completed, the market surveillance agency may allow it to sell within a certain period of time, and the product must continue to complete its compliance evaluation process. .
The competent authorities of member states can also evaluate and organize the procurement of medical devices without CE marking during the outbreak. The product can only be provided to medical workers and cannot be sold on the market. At the same time, spot checks on the market will focus on spot-checking related medical equipment to prevent serious risks caused by substandard products.
02: Personal protective equipment PPE
The masks claiming to be virus-protected belong to Category III according to the PPE regulations, and need to be evaluated for compliance by a notified body authorized by the PPE regulations.
If emergency approval products do not adopt the harmonized standard of PPE regulations as product technical requirements and other technical requirements, such as the recommended requirements of the WHO, they must ensure that the adopted technical requirements have the same level of protection as the basic health and safety requirements of PPE regulations. When the notified body issues certification for such PPE products using other technical requirements, it shall immediately notify the competent authority and other notified bodies of PPE regulations.
If the market surveillance agency determines that the product meets the basic health and safety requirements of the PPE regulations, even if its compliance assessment has not been completed, the market surveillance agency may allow it to sell within a certain period of time, and the product must continue to complete its compliance assessment process .
Competent authorities of member states can also evaluate and organize the purchase of PPE products without CE marking during the epidemic, which can only be provided to medical workers and cannot be sold on the market. At the same time, spot checks on the market will focus on spot-checking related PPE products to prevent substandard products from causing serious risks.
This means that as long as you are in the process of conformity assessment, you can first enter the EU market without the CE mark. The market supervision department conducts spot checks and finds problems before punishing them.
Summarized into three major points:
Member States can purchase medical products that are safe and effective but not CE marked;
Emergency supplies are exclusively for medical personnel and cannot be circulated on the market;
Valid only during an outbreak.
Chinese epidemic prevention supplies have become an important aid to the international fight against the epidemic
With the spread of the epidemic, the demand for masks has exploded, and many Chinese companies have switched to production of masks to help prevent and control the epidemic. At present, the daily production capacity of masks in China has reached 110 million, and countries with severe epidemics such as South Korea and Italy have started to provide masks to Chinese manufacturers. After placing an order, China ’s national defense epidemic materials have become an important aid to the international fight against the epidemic.
According to Alibaba statistics, in the past 30 days, the global buyer ’s willingness to buy masks, hand sanitizers, thermometers and other products related to the epidemic has increased significantly. Among them, the demand for medical mask buyers has increased by 13769%.
Among A-share listed companies, many companies are actively organizing the export of anti-epidemic products. Many companies are applying for FDA approval and CE certification. The release of new EU standards will greatly save the time and cost of export preparation for these companies.
According to incomplete statistics, Yangpu Medical will increase exports of masks, virus preservation solutions and other products to Europe, America and Southeast Asia; Donghua Energy has exported mask raw materials to India, Vietnam and other countries. In the future, the company will arrange export plans according to market conditions.
During the epidemic, Donghua Energy successfully developed a polypropylene meltblown material Y1500H with a melting index of 1500g / 10min in only one week to ensure the production of medical masks.
In addition, Zaisheng Technology considers increasing the export of high-efficiency, low-resistance melt-blown filter materials to the European Union, mainly to overseas markets such as Europe, Japan and South Korea; the international business department of Guoen Co., Ltd. is docking to discuss export of mask materials, and has received inquiries from overseas customers; Shaoneng Co., Ltd. has produced and sold mask machines, and the company is actively expanding overseas orders.
Source: Securities Daily, CSU certification website