Polish project of the legal act implementing MDR and IVDR will also regulate advertising of the medical devices. It's completely new issues (right now there are no regulations in Medicinal Devices Act), so I prepared a short presentation which indicates the key proposals in this matter.

1. Revolution in
advertising of the
medical device in
Poland
Jan Szulc, PhD
jan.szulc@outlook.com

2. Current situation
There is no specific regulation for advertising in Medicinal
Device Act
Advertising of medicinal devices is regulated by general
commercial provisions
In the project of the legal act implementing MDR and IVDR,
there will be chapter which will regulates advertising of
medical devices

3. Key assumptions of advertising
MD
No legal definition (in contrast to advertising medicinal
products)
Definition of advertising in jurisdiction - advertising is what
results in increased sales of goods
List of the specific forms of advertising - avoiding disputes if
some activities fall under the scope of advertising
Including products listed in Annex XVI of MDR

4. Specific forms of advertising
Ads in TV, radio, press, and the Internet
Meetings with the main aim of selling devices
Individual visits to healthcare professionals (HCPs)
Presenting MDs during fairs and conferences
Paid opinions of MDs users - especially in social media (e.g.
influencers)

5. Mandatory element
● name of the manufacturer and name of the MD
● MD intended purpose
● possible contraindications and the risk of using MD
● warning - “before using read the IFU or consult with a
doctor”

6. ● must be understandable for the average user
● cannot suggest that using MD can help avoid
consultation with HCP
● cannot suggest that not using MD will cause health
deterioration
● cannot use terms without established scientific
significance
● use statements or statements that say the product is
infallible, reliable, or that something is certain or
guaranteed
Restrictions

7. ● cannot contain content that may lead to erroneous self-
diagnosis by quoting detailed disease symptoms
● cannot suggest that even a healthy person using the MD
will improve their health;
● cannot contain exaggerated, alarming or misleading
expressions, graphics and other materials depicting
changes in the human body caused by the disease
● cannot use the image of the HCP or fictional institute or
clinic
● cannot be aimed to children
Restrictions

8. Who can advertise MD?
Only manufacturer or his authorised representative (AR)
Other entities - only by written permission of manufacturer
or AR

9. Other issues
Advertising of services where MD are used must respect
provisions of advertising MDs
Fines - up to 0.5M Euro