NISZP, a country’s regulating authority, has published recent advertising rules applicable to both general and in vitro diagnostic (IVD) medical devices. The instruction describes the way advertising activity should be undertaken by all the parties involved in operations with medical devices. The document has been issued by the Medical Devices Control Department.
Table of Contents
Regulatory Background
First of all, the document outlines the scope of regulations it is based on. In particular, provisions of the new rules are based on the regulatory requirements outlined in:
- Medical devices Regulation 2017/745 (MDR);
- In Vitro Diagnostic devices Regulation 2017/746 (IVDR);
- Act no. 40/1995 “On the regulation of advertising”;
- Act no. 89/2021 “On medical devices”;
- Act no. 268/2014 “On in vitro diagnostic medical devices”; as well as other laws and regulations.
The rules apply only to general and IVD medical devices subject to the supervision of the Czech regulating authority in the sphere of medical devices. It is important to mention that the present instruction is non-binding, and is intended to provide additional clarifications and recommendations regarding the advertising rules set forth by existing legislation and the way they should be applied. However, the authority acknowledges that due to the complexity of the issue and the wide range of questions that could be raised concerning advertising rules for medical devices, the interested parties are encouraged to contact the regulating authority and ask for additional clarifications.
First of all, the instruction provides definitions of the most important terms and concepts used in the context of advertising medical devices. In particular, the document provides the following definitions:
- Advertising – announcements, demonstrations, or other presentations disseminated mainly by communication media, aimed at promoting entrepreneurial activity, in particular promoting the consumption or sale of goods, provision of services, etc.
- Advertising for medical devices and in vitro diagnostic medical devices – all forms of information, research, or incentives taken in support of prescribing, dispensing, sale, or use of medical devices and in vitro diagnostic medical devices.
As further describes in the document, advertising activities for medical devices could include, inter alia, visits by sales representatives; supply of samples of medical devices; support for the prescription, supply or sale of medical devices through donations, consumer competition, and offer or promise of any benefit or financial reward; sponsoring meetings held to promote the prescription, sale, supply or use of medical devices; or sponsorship of scientific congresses and other similar meetings involving experts and reimbursement of costs for transport and accommodation related to their participation.
Apart from advertising-specific terms, the document also provides definitions of the general terms, such as “medical device” or “accessory to a medical device”. Additionally, the instruction outlines the scope of products without a specified medical purpose, which is also subject to advertising rules described therein. Such products include, inter alia, contact lenses, as well as different kinds of equipment.
Advertising Rules: Basics
According to the instruction published by the Czech regulating authority, the approach to be applied concerning advertising activity related to the particular product should be determined depending on the regulatory status of such product. For this purpose, it should be determined whether the product in question meets the definition of a medical device and thus is subject to respective regulatory requirements. Moreover, should the product be considered a medical device, information about such a product should be added to the respective database? In this regard the authority mentions that the information to be available remotely should include:
- Information on registered persons handling in vitro diagnostic devices,
- Information on notified IVD devices, and
- Information provided by the manufacturer, authorized representative, importer, or distributor in connection with measures intended to minimize the recurrence of adverse events.
Concerning the database, the document refers to EUDAMED.
General Advertising Requirements
The present instruction provides an overview of the regulatory requirements in the sphere of advertising medical devices and also specifies advertising practices and methods that are explicitly prohibited (e.g., unfair commercial practices, hidden advertisements). The authority acknowledges that advertising activities could significantly impact the perception of medical devices by healthcare professionals and the general public. Thus, it is vitally important to ensure such activities are carried out strictly following the applicable rules and regulatory requirements.
The document further describes different types of advertising activities and highlights the most important aspects associated thereto.
Comparative advertising, directly or indirectly, identifies another competitor or its goods or services. In general, comparative advertising is permissible as far as the comparison:
- Is not misleading,
- Compares only goods and services that meet the same needs or are intended for the same purpose,
- Objectively compares one or more significant, verifiable, and distinctive features, goods or services, including price,
- Compares the goods with the designation of origin only with the goods of the same designation,
- Does not downplay the competitor, its position, its activities or its results or their designation,
- Does not offer the goods or services as imitations or reproductions of the goods or services referred to the trademark or name of a competitor.
Hence, comparative advertising of general and IVD medical devices is permissible, provided the conditions listed hereinabove are met.
Hidden advertising stands for the advertising that is difficult to distinguish as advertising mainly it is not marked as such. The authority explicitly emphasizes that advertising should not pretend to be another form of communication. This includes advertising presented in the form of a report, interview, professional article, educational materials, or non-advertising websites. According to the applicable rules, all advertising materials should be marked in a way making clear that these materials are advertising in their nature and are intended to promote a specific product.
Advertising contrary to good morals is another type of advertising activity that is strictly prohibited. In particular, advertising materials used to promote medical devices, and any statements contained therein should not exploit the fear to impact the decision taken by a consumer.
Unfair commercial practices are deemed to be so if they conflict with the requirements of professional care and significantly distort the behavior of customers. In certain cases, such practices are intended to target a specific audience, which usually constitutes vulnerable groups of customers. Such advertising activities are also explicitly prohibited under the applicable legislation.
In summary, the present instruction provides an overview of regulatory requirements for advertising medical devices marketed in the Czech Republic. The document describes in detail the general advertising rules and requirements and clarifies the particular way they should be applied in the case of medical devices.
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