The Spanish Health Act gives the authorities control over health advertising. In particular, Article 102 refers to the advertising of medical devices, both to healthcare professionals and to the public. This regulatory framework is rounded out by Article 80 of the Spanish Medicinal Products and Medical Devices Act and the provisions on advertising, incentives, and sponsorship of scientific meetings of the Spanish Medical Device Regulation (Spanish MDR) and the Spanish In Vitro Diagnostic Medical Device Regulation (Spanish IVDR).

Apart from the references on medical device claims in the EU Medical Device Regulation (EU MDR) and the EU In Vitro Diagnostic Medical Device Regulation (EU IVDR), this new legislative initiative aims to adapt, update and regulate in greater detail the regulatory framework applicable to the advertising of medical devices. In this regard, the current regulatory framework suffers from a number of shortcomings that should be corrected. Thus, among other goals, the new regulation seeks to (i) identify more clearly the medical devices that are not suitable for advertising to the public; (ii) include specific requirements for devices without an intended medical purpose; (iii) regulate the information and messages in advertising to the public; or (iv) establish mechanisms that enable access to advertising actions for people with sensory disabilities without detriment to the safety and truthfulness of the messages.

This is only a first step in the process to adopt the new regulation on medical device advertising. As the process moves forward, stakeholders will have the opportunity to contribute with their suggestions with a draft text already in place.