The importance of using orthopedic footwear components that have undergone proper quality controls should not be underestimated. Failure to comply with the condition of having the CE marking exposes both the manufacturer and the patient to all kinds of consequences.
Ortoprotésica magazine: Interview with Txema Mendivil
The director of Mendivil talks about the process of obtaining this guarantee, as well as the negative effects of using products without the CE marking.
“Those who decide to risk dealing with suppliers that do not have the CE marking, should be aware that their orthopedic products are not classified as medical devices. The immediate consequence is that footwear manufactured without CE marking will have no value as therapeutic footwear; that is, it will not be able to fulfill the purpose of preserving or improving the health of the users. Furthermore, the use of low-quality products can cause temporary or permanent injuries to patients.”
On the other hand, Txema Mendivil points out that these practices, carried out by some orthopedic workshops, constitute a fraud. Patients in this case can file lawsuits and request large compensation for damages. In addition, this type of action represents a serious infringement: the financial penalties derived from it are contemplated in article 99 of Royal Decree Law 1/2015, and can reach very high amounts, depending on their severity.
What is meant by CE marking in medical devices?
It is a fundamental indicator that since 1993 guarantees the conformity of a product with European legislation. This symbol CE must have a size not less than 5 mm and conform to a pre-established design, placed on the product itself.
Under its sole responsibility, the manufacturer that adds this CE marking, certifies its adherence to current legal requirements. This, in addition, is essential so that your product can be distributed and sold in the European market. The requirements that these orthopedic footwear must meet refer specifically to health, environmental protection and, above all, user safety issues.
Orthopedic workshops and its suppliers have to meet a series of conditions to obtain this guarantee. Among them is having the mandatory operating license granted by the Drug & Medical Device Spanish Agency (AEMPS). They must also demonstrate that their staff is qualified and in continuous training, and that they maintain quality controls regarding their raw materials and finished products.
Mendivil, aware of the importance of the feet for the health and independence of patients, fully complies with current regulations.