The draft regulation of the Minister of Health on medical device advertising (the Draft) provides for further restrictions and requirements on advertising to the public. The Draft is intended to be a clarification of the technical requirements for advertising medical devices that have been introduced at the statutory level in the Polish Medical Devices Act of 7 April 2022 (the MDA).
Mandatory elements in advertising
According to the Draft, the advertisement directed to the public must contain:
• contraindications to the use of the device (if applicable),
• information on the probable risks associated with the use of the device,
• the name of the manufacturer and the authorised representative (if appointed),
• information that the product is a medical device,
• warning – its content and the manner how to place or read the warning are specified in the Draft,
• information about the benefits received from the advertiser (in certain cases – see below).
In addition, the MDA stipulates that every advertisement (both directed to the public and to non-laymen) needs to contain the name of the medical device and its intended purpose.
Information on benefits
According to the current version of the Draft, medical device advertising must indicate information on all benefits received from the advertiser in case of the following types of advertising:
• directing opinions to the public by device users, if they receive benefits from it,
• visiting healthcare professionals to promote devices,
• sponsorship of trade fairs, exhibitions, shows, presentations, conferences, conventions and scientific congresses, including those for healthcare professionals or traders of devices, and/or presenting devices during such events.
This information should be placed in graphic or audio form. However, the Draft does not provide for any specific content of such information.
In addition, the Draft stipulates requirements for the medical device advertising directed to the public in pharmacies and medical facilities.
The Draft is currently under public consultation and its final form is unknown.
By Agnieszka Majka, Partner, Celina Bujalska, Senior Associate, and Paulina Roslon-Horosz, Junior Associate, NGL Legal