The Spanish Agency for Medicines and Health Products (AEMPS) under the Ministry of Health has issued an important warning. As described in the statement, They found a fake CE marking, which is used to certify medical devices in Spain and other European countries. So the body is ordering the removal of all these devices, and there are more than you can imagine.

Among the products identified by false certification, blood pressure monitors, thermometers, suction cups, nebulizers, digital color doppler and hearing aids. Since these are vital medical devices for the health of millions of people, the situation has become much more worrying. Indeed, without CE marking, it is difficult to establish whether these devices comply with the quality and safety standards set by the current regulations.

The German health authorities were the first to learn of the situation. Soon after, they warned the rest of the European Unionan obligation that Member States must ensure that medical devices in the region comply with the regulations.

False CE marking has already been detected, and these are the products with the number 0483/N50569-14-7, owned by the German organization MDC Medical Device Certification GmbH. This code was used to support marketing by Prolinx GmbH in Germany. Issued on December 8, 2019, valid until July 2, 2023.

For its part, Health confirms in a statement that each autonomous community will be responsible for tracking and subsequent removal the aforementioned devices on the market.

Monitor the CE certificate of your devices and report counterfeit medical devices.

Obtaining the CE marking is a rather long and complicated process. The mentioned certificate is issued only after an exhaustive check of the products. There, such sections as safety, efficiency and quality, established by the regulation, are evaluated. Some companies resort to counterfeiting, either by not meeting these requirements or by speeding up its time to market.

Now that the Department of Health has issued a warning, it is important that consumers and organizations be careful about the origin of these items. If you belong to the first group You can always view the CE code of the medical devices you purchase.. You can usually find it on their surface along with the certificate logo. It can also be seen on the packaging.

If you have any product associated with the above warning, It is important that you contact the health authorities in your autonomous community.. In this way, you can help take these devices out of circulation and prevent the damage they can cause.

Source: Hiper Textual

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