As Europe has replaced China as the worst hit area of the COVID-19, the urgency of taking action to fight the epidemic has risen rapidly. At present, the European Union has announced the relaxation of import requirements for medical supplies, and medical products without CE markings can also be sold to Europe.
On March 13th, the European Commission released new regulatory recommendations for the medical supplies market. Overall, the committee recommends that European countries relax the procedural requirements for product supervision, allowing products to be sold as long as they meet the basic safety and performance requirements of medical devices, even if compliance evaluation has not been completed.
In addition, the committee proposed that governments of various countries can also purchase medical devices without CE markings through official organizations and provide them to medical workers for use. During the use process, market supervision departments will conduct spot checks, and if problems are found, penalties will be imposed. At the same time, such products are not allowed to enter the market for circulation and sale.
The "CE" mark is a safety certification mark that is considered a passport for manufacturers to open and enter the European market. The "CE" mark is a mandatory certification mark in the EU market. Whether it is products produced by enterprises within the EU or products produced in other countries, in order to freely circulate in the EU market, the "CE" mark must be affixed to indicate that the product meets the basic requirements of the EU's "New Methods for Technical Coordination and Standardization" directive.