In the field of aesthetic medicine, patient safety and legal compliance are fundamental elements. Therefore, both European and Spanish legislation establish that certain medical devices can only be purchased and used by qualified healthcare professionals, especially physicians. But what is the reason for this clear and restrictive regulation?
-
The use of medical devices requires specialized medical training
Medical devices such as dermal fillers, medically used chemical peels, thread lifts, or devices for advanced treatments are designed to act at a deep level in the skin or subcutaneous tissue. Their application involves risks that only a physician can assess, prevent, and treat if necessary. University medical education provides the essential anatomical, physiological, and clinical knowledge to ensure safe and effective use.
-
Spanish legal framework: Law 14/1986 and Royal Decree 1591/2009
In Spain, the use and distribution of medical devices are regulated by:
Law 14/1986, General Health Law, which establishes that healthcare actions must be performed by qualified healthcare personnel.
Royal Decree 1591/2009, which regulates medical devices, and whose transposition of Regulation (EU) 2017/745 of the European Parliament requires that the use of certain products be reserved for healthcare professionals with official qualifications and professional registration.
Additionally, according to the Spanish Agency of Medicines and Medical Devices (AEMPS), both distributors and medical centers must ensure that these products are only delivered to authorized personnel, under strict traceability and control criteria.
-
Clinical responsibility and professional ethics
Beyond the legal aspect, there is medical responsibility. Only a physician can perform a complete medical history, detect contraindications, choose the appropriate treatment, and act in the event of adverse effects. This capacity for analysis and response is key to protecting patient health and ensuring safe and natural results.
-
Preventing professional intrusion and protecting the patient
Unfortunately, professional intrusion in the aesthetic sector remains a problem in Spain. Allowing the use of medical devices by individuals without medical training is not only illegal but also dangerous. Respecting the current legal framework helps preserve the quality of the sector, protect patients, and dignify medical practice.
At Piel Eterna, we are firmly committed to legality, ethics, and safety. For this reason, we work exclusively with registered physicians and certified products. Because beauty is important, but health is essential.