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EU launches green channel: Chinese mask exports, no CE mark required!

The new coronavirus has spread throughout the world, adding another 10 countries in the last 3 days, at least 43 countries in the world have entered a state of emergency, and at least 18 countries in Europe have entered a state of emergency. "Nonessential travel" for 30 days.

The EU opens the green channel without CE marking,

Access to the European Union for medical workers.

 

 

 

On March 13, 2020, the European Union membership published recommendations for compliance assessments and market surveillance procedures for medical devices and personal protective equipment (PPE) during the epidemic in the Official Journal of the European Union.

 

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 can 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 mark during the epidemic period. This product can only be used by 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.

 

Personal protective equipment (PPE):

◆ The products involved include disposable and reusable masks, reusable work clothes, gloves and eye masks (mainly products for preventing viruses and harmful substances). Requires a Notified Body authorized by the PPE regulations to conduct compliance assessments.

 

◆ If the emergency approval product does not adopt the harmonized standard of PPE regulations as the product technical requirements and other technical requirements, such as the recommended requirements of the WHO, it must ensure that the adopted technical requirements have the same level of protection as the basic health and safety requirements of the 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 evaluation has not been completed, the market surveillance agency can allow it to sell within a certain period of time, and the product must continue to complete its compliance evaluation process.

 

◆ Competent authorities of member states can also evaluate and organize the purchase of PPE products without CE marking during the epidemic period. This product can only be used by 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.

 

In other words, 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.

 

The key points are as follows! !! !!

◆ Member states can purchase medical products that are safe and effective but not CE marked;

 

◆ Emergency supplies are dedicated to medical personnel and cannot be circulated on the market;

 

◆ Effective only during the outbreak.

 

 

About CE marking

The CE label is like a giant umbrella. Below it are various EU directives that stipulate various product safety standards, subdivided into different materials and production modes. Since its establishment in 1985, it has become a mark of high quality, high standards and strict law enforcement. Products lacking this mark will not be allowed to enter the EU market.

 

Today, the CE mark has become a globally recognized quality mark. The CE mark can prove that the batch of products manufactured in the EU or imported into EU member states meets quality standards and meets the requirements of protecting consumer health, supply chain safety and environmental sustainability.

 


Post time: Mar-20-2020