The CE marking, the guarantee of your medical products

The CE marking is the seal of quality and safety that all products sold within the European Union must have, regardless of whether they are manufactured in Europe or outside of Europe. This label (CE) indicates that the product complies with the standards and meets all the requirements set by the European Directive in order to be used with all the health and safety guarantees.

SEME wants to take this opportunity to remind all doctors that the devices they use in their offices to perform treatments on patients (laser, cavitation, carboxytherapy, etc.) must be duly authorized and approved, and be provided with the CE certificate, class IIb, of the General Directorate of Pharmacy and Health Products of the Ministry of Health and Social Policy.

The Spanish Agency for Medicines and Health Products (also framed within the Ministry of Health and Social Policy) is the body that certifies that these articles for clinical use comply with the Health Products Directive.

As the CE marking authorizes the medical device to be freely sold and used throughout Europe without further registration or national approval, it is relatively easy for counterfeits to slip through. The sanctions for these forgeries are considered serious by current legislation and are administrative in nature, notwithstanding that there may be other criminal, civil or other responsibilities in relation to this fact.

Directive 93/42/EEC is the European law that regulates that no sanitary article can be marketed in European territory without the CE Medical Device CE Marking, and its transposition into Spanish legislation is Royal Decree 1591/2009 , of October 16, by which sanitary products are regulated (BOE no. 268). This Royal Decree covers all the actors in the health scene: manufacturer, distributor, doctor, operator and patient, since only one of them cannot guarantee the safety and efficacy of the products.