Concept and Regulation
The advertising of medical devices in Spain is subject to strict regulations due to the particular characteristics of these products. The principal regulations governing this area include:
- Regulation (EU) 2017/745, of the European Parliament and the Council, of April 5, 2017, on medical devices, amending Directive 2001/83/EC, Regulation (EC) 178/2002, and Regulation (EC) 1223/2009, and repealing Council Directives 90/385/EEC and 93/42/EEC.
- Royal Decree 192/2023, of March 21, regulating medical devices.
- Royal Decree 1591/2009, of October 16, regulating medical devices. Although repealed by RD 192/2023, articles 38, 39, and 40 remain in force regarding advertising, promotion, incentives, and sponsorship of scientific meetings until the development of specific legislation.
- General Advertising Law 34/1988, of November 11.
- General Health Law 14/1986, of April 25 (Articles 27 and 102).
- Law 29/2006, of July 26, on Guarantees and Rational Use of Medicines and Medical Devices (LGURMPS).
Definition of Medical Devices
According to Regulation 2017/745, medical devices are:
Instruments, apparatus, appliances, software, implants, reagents, materials, or other articles intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease.
- Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or a disability.
- Investigation, replacement, or modification of the anatomy or a physiological or pathological process or state.
- Providing information employing in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- Devices for the control or support of conception;
- Products specifically intended for the cleaning, disinfection, or sterilisation of medical devices and their accessories.
Therefore, medical devices cover a broad range of healthcare-related products that do not fall under the medication category. These include devices, materials, instruments, and even software.
Furthermore, medical devices are classified into different classes according to the risk level they pose to patients: Class I, IIa, IIb, and III (Class I being the lowest).
Target Audience of Advertising
Healthcare Professionals
Information and promotional materials, whether written, audio-visual, or in any other format, must be primarily scientific and directed exclusively at healthcare professionals.
General Public
Advertising directed at the general public is subject to additional requirements:
The promoted medical devices
- Must not be financed by the National Health System.
- Must be designed for use without a doctor’s intervention for diagnosis, prescription, or treatment monitoring, although the involvement of a pharmacist may be necessary. Health authorities may exempt vaccination campaigns from this requirement.
- Must not contain psychotropic or narcotic substances as defined by international conventions.
Advertising messages must
- Indicate their advertising nature and specify that the product is a medical device.
- Include the product name and necessary information for proper use.
- Feature a clear and visible invitation to read the instructions of the package leaflet or external packaging, along with a recommendation to consult a pharmacist for correct use.
- Not claim guaranteed cures or feature testimonials from professionals or celebrities endorsing the product that might induce consumption.
- Do not use regulatory approvals, certifications, registrations, or health authority controls as an advertising argument.
- In audio-visual advertising, comply with accessibility standards for people with disabilities.
- Not reference health authorities or recommendations from scientists, healthcare professionals, or other well-known individuals who could encourage use (except in public administration campaigns).
Prior Authorisation for Advertising
Advertising medical devices in mass media, including the Internet, requires prior permission from the health authority in the autonomous community where the advertising company is. If the advertisement aims at a specific autonomous community, that region is responsible for granting it. If the advertiser is not in Spain, the authorisation falls to the autonomous community where the advertising medium operates. Since regional regulations apply, compliance with local laws is necessary.
Advertisers and Content of Advertising
Advertising information must:
- Be provided by qualified individuals with sufficient knowledge to offer accurate and complete guidance.
- Include technical data necessary for an objective assessment of the medical device.
- Indicate compliance with current legislation, contraindications, and potential side effects.
- Prohibit offering or promising financial or material incentives to healthcare professionals, their families, or cohabitants in exchange for prescriptions or recommendations.
Sponsorship of Scientific Meetings
Promotion of medical devices at scientific meetings is allowed if the events are strictly professional and scientific. Hospitality, either directly or indirectly provided to healthcare professionals, must be moderate and aligned with the primary educational purpose of the event.
Infractions and Sanctions
Failure to comply with advertising regulations for medical devices in Spain constitutes a serious offence, subject to fines ranging from:
- Minor offenses: €30,001 – €60,000
- Moderate offenses: €60,001 – €78,000
- Severe offenses: €78,001 – €90,000
Conclusion
Medical device advertising in Spain is highly regulated to ensure consumer safety and protection. Companies in the sector must understand and comply with legal requirements to avoid penalties and maintain responsible and effective communication.
If you need legal advice regarding the advertising of medical devices in Spain,
