EU opens green channel for export of masks, can be sold without CE certification
xinst3月 26, 2020
On March 20th, the European Union issued a directive. In the face of the new crown epidemic, in order to meet the growing demand for masks, protective clothing and other epidemic prevention supplies, some epidemic prevention materials (such as a class of sterilized medical masks) are allowed to meet safety and effectiveness, It has not obtained CE certification and can also be sold in the EU market.
Earlier, the US FDA also opened a similar green channel for new crown virus detection products, allowing detection kits to enter the clinical market before they have been authorized by the EUA.
Valid only during the epidemic period
On March 13, 2020, the European Union membership published recommendations in the Official Journal of the European Union for conformity assessment and market surveillance procedures for medical devices and personal protective equipment (PPE) during the outbreak.
The 93/42 / EEC medical device directive covers two broad areas:
(EU) 2017/745 Medical devices related to the epidemic covered by medical device regulations, such as medical masks, inspection gloves, and some isolation clothing.
(EU) 2016/425 PPE regulations cover personal protective equipment related to the epidemic, such as anti-particle masks and eye masks.
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%.
It is understood that for the European market and the US market, general masks exported to the United States require FDA (US Food and Drug Administration) approval, and export to Europe requires CE certification (EU mandatory product certification).
The opening of the green channel by the European Union and the United States will greatly facilitate the circulation of epidemic prevention materials, which is of great significance for epidemic prevention and control. Chinese-made masks and other epidemic prevention materials will quickly help prevent and control epidemics abroad.
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