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Advertising of medical devices part 1.


 

We increasingly come across questions about advertising medical devices - so we are reminding you of the general rules especially for you.

 

🔸Advertising addressed to the public is considered as advertising addressed to the average consumer, therefore it must meet certain requirements.

 

(1) It must be understandable, i.e. the content of which will be clear to the layman. This requirement applies to medical and scientific terms, referenced scientific studies, opinions or papers.

(2) Advertising to the public must not use the image of medical professionals, but also the image of actors playing the role of medical professionals. Nor should the persons presenting the product behave in a way that suggests a medical profession.

(3) Advertising must not contain direct messages to children to encourage them to purchase medical devices or to persuade parents or other adults to buy advertised medical devices for them.

(4) Medical devices intended for professional use must not be advertised to the public.

 

🔸Advertising may not mislead as to the terms and conditions of maintenance, periodic or ad hoc servicing, software updates, periodic or ad hoc overhauls, adjustments, calibrations, calibrations, checks or safety checks of a given type of device, including the requirements concerning the technical equipment of the entities performing these activities and the qualifications of the persons employed therein.

 

🔸Advertising may be conducted in audiovisual, visual or audio form and must include at least:

1. the name of the medical device and its intended use

2. identification of the advertiser,

3. the name of the manufacturer and the authorised representative - if appointed

4. a warning: "This is a medical device. Use it in accordance with the instructions for use or the label'.

 

🔸The content of the warning in the case of advertising in audiovisual form:

(a) must be placed at the bottom of the advertisement, on a plane representing not less than 15% of its surface area,

(b) it shall be positioned in such a way that the text stands out from the background of the plane, is visible, legible, fixed, placed horizontally, with the distance of the letters from the lower and upper edges of the background of the advertising plane being no more than 1/2 the height of the letters, and the distance between the lines of the inscription being no more than the height of the letters,

(c) it must be read clearly in Polish and its duration must not be shorter than 4 seconds;

 

🔸The content of the warning in the case of an advertisement in audio form shall be clearly read out in Polish and its duration shall not be shorter than 4 seconds.

 

🔸The content of the warning in the case of advertisements in visual form shall be placed:

(a) at the bottom of the advertisement, on a plane representing not less than 10% of its area,

(b) in such a way that the text stands out from the background of the plane, is visible, legible, fixed, placed horizontally, with the distance of the letters from the lower and upper edges of the background of the advertising plane being no more than 1/2 the height of the letters, and the distance between the lines of the inscription being no greater than the height of the letters.

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