Legal Basis for Medical Device Advertising
Although Regulation MDR 2017/745 does not directly regulate advertising, it emphasizes transparency, consistency with the technical documentation, and alignment with the intended purpose of the device. In Poland, specific national rules are included in the Medical Devices Act and the 2023 regulation. These apply regardless of the medium (internet, print, video) or audience (layperson or professional). For IVD devices, IVDR 2017/746 also applies, requiring clear identification of the intended purpose and audience of the promotional communication.
Who Is Responsible for Advertising?
The entity conducting the promotion—typically the distributor, importer, or manufacturer—is responsible for the content of the advertisement. Responsibility also extends to situations where an external agency runs the campaign; in such cases, every ad version must be approved in writing before publication.
Advertising samples and a list of publication locations must be stored for at least two years, including for online ads. This documentation must be made available upon request from the President of URPL. These elements should be integrated into the QMS and the procedure for review and approval of promotional materials by the PRRC, in accordance with Article 15 of MDR/IVDR.
Requirements for Medical Device Advertising
Each medical device advertisement must be:
- consistent with the technical documentation and intended purpose,
- understandable to laypersons—even if directed at professionals,
- free from misleading elements,
- supplemented with required warnings (e.g., “This is a medical device. Use in accordance with the instructions for use or labeling.”).
For IVD products intended for laboratories, marketing materials must not suggest performance outcomes that exceed those declared in the Performance Evaluation Report.
If use of the device involves risks, these must be clearly indicated—including in audio and visual form for audiovisual advertising.
What Is Prohibited in Medical Device Advertising?
Medical device advertisements must not:
- suggest therapeutic properties that the device does not possess,
- use the image of doctors, nurses, or pharmacists,
- target children or imply their influence over adult decisions,
- advertise professional-use-only devices as suitable for laypersons,
- claim the device requires no servicing if servicing is required.
It is also illegal to suggest that a device has been “approved” by URPL or other authorities—MDR and IVDR do not include any mechanism for public authority approval of advertisements.
What Qualifies as Advertising?
Advertising includes not only traditional campaigns but also:
- publishing user reviews in exchange for benefits,
- presenting a device at an industry event with purchase incentives,
- sponsoring events where a specific product is promoted,
- offering free samples for marketing purposes,
- sales rep visits to professionals.
Any form of commercial communication that increases product recognition qualifies as advertising—even if it lacks pricing or calls to action.
Not considered advertising: catalogues, price lists, and instructions—provided they contain no persuasive elements.
Online and Social Media Advertising
All online advertising forms are also subject to regulations:
- manufacturer/distributor websites,
- Meta Ads, Google Ads, banners, email campaigns,
- influencer collaborations—including micro-influencers!
Every form of promotion must contain required information and must not be misleading—regardless of format or placement. Particular care is required for remarketing campaigns and SEO/SEM activities, which are fully subject to the Medical Devices Act.
Consequences of Non-Compliance
Consequences of violating regulations include:
- prohibition of ad publication,
- mandatory removal and publication of the URPL decision,
- fines ranging from PLN 50,000 to PLN 5,000,000,
- immediate enforceability of URPL’s decision.
Additionally, failure to maintain a register of promotional materials may be considered a QMS violation, leading to findings during internal audits or regulatory inspections.
How Pure Clinical Supports Legal Marketing
We help companies navigate complex advertising regulations safely. We offer:
- review and approval of advertisements prior to publication,
- implementation of procedures in line with legislation,
- training for marketing, sales, and management teams,
- full support during URPL inspections,
- development of RACI matrices for PRRC and marketing teams regarding promotional material approval.
FAQ
Does the PRRC need to approve all advertising content before publication?