The New Year will be full of legal changes, particularly those that aim to further protect consumers. On January 1, 2023, among other things, the provisions of the Law of April 7, 2022 on the advertising of medical devices come into force. What does the new regulation provide for?
At the outset, it should be mentioned that the Law of April 7, 2022 on medical devices came into force on May 26, 2022, with the exception of some provisions, including those specifically concerning the advertising of medical devices. These are Articles 54 – 61, which will take effect precisely on January 1, 2023. The new regulation introduces significant prohibitions and restrictions on medical device advertising. In addition to the aforementioned law, the advertising of medical devices should also bear in mind EU regulations, i.e. in particular Article 7 of Regulation 2017/745 or Article 7 of Regulation 2017/746.
Explanation of relevant terms
Before we go into detail about the new regulation of medical device advertising, it is worth clarifying some important concepts that appear in the regulations.
Let’s start with the concept of medical devices. These are any product or device that has been classified as a medical device by its manufacturer, regardless of its class. In order to determine whether medical devices are being used in an activity, it is therefore necessary to consult the leaflet/instructions or other documentation provided by its manufacturer. This documentation will also indicate whether the use of the medical device requires special qualifications (which will involve, for example, practicing a specific medical profession), or whether there is no such restriction, so the medical device can be used by anyone. Examples of medical devices include ultrasound and MRI equipment, lasers, as well as ordinary bandages, catheters, as well as heart valves, breast implants, dental implants, needles, syringes. Aesthetic medicine uses medical devices such as IPL and biostimulation lasers or fractional lasers, hyaluronic acid, but also platelet-rich plasma kit.
In connection with the changes to the regulations under discussion, it will be important for an entity using medical devices in its operations to determine whether, according to the manufacturer’s information, the use of these medical devices requires special skills/qualifications and therefore only those with the appropriate training may use them, or whether there are no such restrictions and the medical devices can be used by anyone, i.e., by so-called laymen.
Here we come to another important concept, that is, we will explain who is a layman. This refers to a person who has no formal training in the relevant field of health care or medicine and who is not a health care professional. Thus, in terms of the Law on Medical Devices, laypersons will be clients/patients to whom qualified persons apply procedures/treatments using medical devices, but also cosmetologists and beauticians, among others. Why does the latter group qualify as laymen? Because these professions are not regulated by law, so they cannot be considered to have “formal training in the relevant field of health care or medicine.”
The last concept still worth clarifying before describing the statutory regulation of medical device advertising is “advertising directed to the public.” This refers to any activity that is intended to encourage potential customers to purchase a good or service, aimed at an unlimited audience.
What advertising of medical devices is allowed and what is prohibited?
Let me start by saying what kind of advertising is completely prohibited under the law. It is about advertising to the public for medical devices intended for use by users other than laypeople. Thus, it is forbidden to advertise medical devices, which, according to the manufacturer’s information, can only be used by people with certain education/qualifications, that is, in practice, representatives of the health or medical professions (I will continue to refer to them as “medical professionals” for short). It is not about advertising a specific medical device, but also about any treatment using the aforementioned medical devices.
Advertising to the public concerning medical devices intended for use by laypeople is permissible. However, the law introduces important requirements and thus restrictions on this type of advertising. The purpose of the regulation is to protect laypersons, that is, in practice, mainly consumers.
What requirements must therefore be met by legal advertising of medical devices intended for laypersons? Well:
- it must not violate the prohibitions referred to in Article 7 of Regulation 2017/745 or Article 7 of Regulation 2017/746,
- it must be formulated in a way that is understandable to a layperson. This requirement also applies to medical and scientific wording, as well as to the citation in advertising of scientific studies, opinions, literature or scientific papers and other materials aimed at users other than laymen,
- it must not use the image of persons engaged in the medical profession or claiming to be such persons, or depict persons presenting the product in a manner suggesting that they are engaged in such a profession,
- it may not contain a direct appeal to children to purchase advertised products or to persuade parents or other adults to buy advertised products for them,
- it may not misrepresent the terms and conditions of maintenance, periodic or ad hoc servicing, software updates, periodic or ad hoc inspections, adjustments, calibrations, checks or safety inspections of the type of products in question, including the requirements for the technical equipment of the entities performing these activities and the qualifications of the persons employed therein.
Importantly, the provisions of the Law on Medical Devices regarding advertising, so the prohibitions and restrictions indicated above, also apply to:
- advertising of business or professional activities in which a device is used to provide services – to the extent that it concerns services provided with the use of a given device, including services of lending, renting or lending of devices;
- presenting products at meetings whose purpose or effect is to encourage the purchase of products, or financing such meetings;
- directing opinions to the public by users of the devices if they receive benefits from doing so;
- visiting medical professionals to promote products;
- sponsoring fairs, exhibitions, demonstrations, presentations, conferences, conventions and scientific congresses, including for medical professionals or those who trade in devices, and displaying devices at events,
- providing samples to promote products.
The concept of medical device advertising is broad, but the provisions of the law clearly indicate what is not considered medical device advertising. These are trade catalogs or price lists, which contain only the trade name, the price of the device or the technical specifications, as well as information placed on packaging and attached to the packaging of devices, as required by the Law and Regulation 2017/745 or Regulation 2017/746.
Additional obligations related to advertising of medical devices
Business entities that will conduct advertising of medical devices directed to the public to the extent permitted by the Law and EU regulations must still remember the obligation to store advertising templates and information about the places of its dissemination for a period of 2 years from the end of the calendar year in which the advertisement was disseminated. At the request of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, a business entity advertising medical devices is required to make available a specimen of each advertisement directed to the public, together with information on the manner and period of its dissemination. In turn, a media service provider or publisher is obliged to make available, upon request by the President of the aforementioned Authority, the names and addresses in its possession of businesses or individuals placing paid advertisements or announcements, as well as any other materials related to advertising. Media service providers or publishers are also required to keep the above information and materials, for a period of not less than one year.
What about ads published before January 1, 2023?
Advertising of devices whose distribution began before the effective date of Articles 54-61 of the Law on Medical Devices, which do not meet the new legal requirements, may be distributed no longer than June 30, 2023. This means in practice that any entities advertising medical devices by the end of the first half of 2023 should review the content published to date. If they do not meet the requirements of the Medical Devices Law, they should be brought into compliance with the new regulation, and if this is not possible, they will have to be removed by a maximum of June 30, 2023.
Consequences of violating advertising bans and restrictions
Violations of the Act or EU regulations can cost heavily. Conducting advertising of devices in a manner contrary to Article 7 of Regulation 2017/745, Article 7 of Regulation 2017/746 or Articles 54-60 of the Law on Medical Devices is subject to a fine of up to PLN 2,000,000. In turn, failure to store or make available advertisements, information or materials indicated in Article 61(1)-(4) of the Law on Medical Devices by advertising operators or media service providers or publishers of advertisements shall be subject to a fine of up to PLN 50,000.
What action should be taken?
To prepare for the new regulations, first determine whether you use medical devices at all in your business or profession. You will do this based on the instructions, leaflets and other documentation provided by the manufacturer of the product/device in question. If you do not use medical devices, the prohibitions and restrictions discussed in this post do not apply to you.
If, on the other hand, you determine that you are using medical devices, verify in the documentation provided by the manufacturer what their intended use is, i.e. whether they can only be used by medical professionals or laypeople as well.
Those medical devices that are intended for use only by medical professionals will not be allowed to be the subject of advertising to the public. If you have previously advertised them, you should remove any advertising materials.
For medical devices intended for use by laypeople, verify the advertisements you have published so far. If they do not comply with the new regulations, bring them into compliance with the new requirements by June 30, 2023, and remove them if this is not possible. New advertising activities undertaken as early as January 1, 2023 must comply with the new regulation.
advocate Agnieszka Rapcewicz