MADRID – The Spanish Medicines and Medical Devices Agency (AEMPS), a division of the Ministry of Health, has issued a warning regarding medical products in Spain.
These products, including clinical thermometers, blood pressure monitors, and hearing aids from the manufacturer Prolinx GmbH, are being traded in Spain with counterfeit CE marking certificates. As a result, these products lack the necessary authorisation according to European regulations. This action has been taken for “market control” purposes, enabling the competent authorities to take appropriate measures.
Devices for Diagnosis and Medical Care
Specifically, the identified products suspected of being traded with counterfeit markings include sphygmomanometers, thermometers, suction devices, nebulisers, colour Dopplers, and hearing aids, according to the statement released by AEMPS. These devices are used for diagnosis, medical care, and compensating for sensory deficits.
“A false CE marking certificate has been detected on blood pressure monitors, thermometers, a suction machine, nebulisers, digital colour Doppler and headphones”. These have the number 0483/N50569-14-7, from the German notified body MDC Medical Device Certification GmbH, whose identification number is 0483 for the manufacturer Prolinx GmbH, Germany, explains the AEMPS statement.
The certificate has an issuance date of December 8, 2019, and an expiration date of July 2, 2023.
What is the CE marking
The CE marking is a symbol by which the manufacturer or legally responsible party declares under its responsibility that the product it is marketing, after carrying out an evaluation procedure, has complied with the essential health and safety requirements that are included in the regulation corresponding to the product.
Notification by German Authorities
The health authorities in Germany issued the notification regarding the counterfeit products. This action is in response to the obligation of European Union member states to collaborate and ensure that medical goods placed on the common market comply with European regulations.
Enhanced Oversight Post-Pandemic
Following the increased sales of medical products during the pandemic, particularly masks and rapid tests, without proper guarantees or accreditation, oversight measures have been intensified.
