Radio spots and spoken promotions for medical devices in Poland

Professional-use devices cannot be publicly advertised

Legal requirement — paraphrased

Applies when: The advertised offer is a regulated device or IVD.

For a regulated device/IVD, public advertising cannot concern a device intended for users other than laypersons. Public creative cannot use healthcare professionals, people posing as them, or presentations suggesting that profession; nor directly urge children to buy or persuade adults to buy.

Sources: Medical Devices Act — consolidated working text based on Dz.U. 2024 item 1620 · Article 55

Keep device claims within the assessed intended purpose

Legal requirement — paraphrased

Applies when: The advertised offer is a regulated device or IVD.

If this is a device/IVD, do not invent functions, diagnostic performance or safety; imply unassessed uses; or obscure likely risks. Do not mislead about servicing or software updates. Explain claims in language a layperson can understand.

Sources: URPL — Advertising medical devices; Medical Devices Act — consolidated working text based on Dz.U. 2024 item 1620 · MDR/IVDR Article 7 as explained by URPL; Device Act Articles 54–55

Obtain written approval and keep device-advertising records

Legal requirement — paraphrased

Applies when: The advertised offer is a regulated device or IVD.

For a regulated device/IVD, an advertiser other than the relevant economic operator needs that operator's written approval. Keep public-advertising specimens and placement information for two years after the end of the calendar year of dissemination; media providers/publishers have a separate minimum one-year retention duty.

Sources: URPL — Advertising medical devices · Device Act Articles 56 and 61, explained by URPL

Include device identity and the correct Polish warning

Legal requirement — paraphrased

Applies when: The exact message is public device advertising, including qualifying device-based service advertising under Article 58.

Apply this module only to qualifying public device advertising, including a device-based service falling within Article 58. It does not make an otherwise prohibited advertisement permissible.

For public device/IVD advertising, identify the advertiser, manufacturer and appointed authorised representative, alongside device name and intended purpose. The warning is: To jest wyrób medyczny. Używaj go zgodnie z instrukcją używania lub etykietą.

For Annex XVI non-medical-purpose products and device accessories, the regulation instead specifies: Dla bezpieczeństwa używaj zgodnie z instrukcją używania lub etykietą. Determine the correct branch before drafting.

Sources: Medical-device advertising regulation — Dz.U. 2023 item 817; Medical Devices Act — consolidated working text based on Dz.U. 2024 item 1620 · Sections 1–3

Fit device warnings to image, audio or video

Legal requirement — paraphrased

Applies when: The exact message is public device advertising, including qualifying device-based service advertising under Article 58.

Apply this module only to qualifying public device advertising, including a device-based service falling within Article 58. It does not make an otherwise prohibited advertisement permissible.

Audiovisual: warning in the bottom 15% or more, clearly spoken in Polish for at least four seconds. Audio: at least four seconds of clear Polish warning. Visual: bottom 10% or more, on the first page of multipage advertising. Observe the prescribed contrast, static horizontal text and spacing.

Sources: Medical-device advertising regulation — Dz.U. 2023 item 817; Medical Devices Act — consolidated working text based on Dz.U. 2024 item 1620 · Section 3(3)

Identify the operator responsible for advertising approval

Regulator guidance

Applies when: The offer is a regulated device or IVD.

Written approval for an outside advertiser does not transfer the economic operator’s statutory responsibility to the agency or creator. Keep approval and publication records attached to the exact version of the advertisement.

The economic operator’s two-year period runs from the end of the calendar year of dissemination. The separate media-provider/publisher minimum is one year; these are different duties.

Sources: URPL — Advertising medical devices · URPL overview: written approval, responsibility and retention; Act Articles 56 and 61

Make the overall message truthful and commercially identifiable

Legal requirement — paraphrased

Misleading claims, material omissions, hidden commercial intent and aggressive consumer marketing are prohibited. Assess visuals, comparisons, qualifications and the impression on vulnerable consumers. Do not falsely claim that a product cures illness.

Editorial control: retain substantiation before publication, remove fabricated urgency or authority badges, and check that qualifications do not contradict the headline. Paying to publish apparently independent advice must not conceal its commercial nature.

Sources: Act on Counteracting Unfair Market Practices — consolidated text, Dz.U. 2023 item 845 · Articles 4–9; Article 7 hidden advertising and false cure claims

Check price reductions only after establishing that promotion is lawful

Legal requirement — paraphrased

Where an advertisement announces a reduction for a good or service, state the relevant lowest price from the preceding 30 days alongside the reduced price. For a shorter selling history, use the lowest price since sales began; special rules apply to rapidly perishable goods.

This consumer-information rule does not permit a discount or purchasing incentive prohibited by medicine or service rules. As an editorial check, make the total scope and extra charges clear.

Sources: UOKiK — Information about price reductions · Price Information Act Article 4 as explained by UOKiK

Keep reviews genuine and explain verification

Legal requirement — paraphrased

Do not publish, commission or distort false consumer recommendations. If making consumer reviews available, explain whether and how their origin is verified. Do not claim authentic-user verification without reasonable, proportionate checks.

Selecting a patient or customer story for advertising also requires checking the sector's claims and endorsement restrictions. A genuine testimonial can still contain an unlawful health claim.

Sources: UOKiK — False reviews? Stop!; Act on Counteracting Unfair Market Practices — consolidated text, Dz.U. 2023 item 845 · Unfair-practices Act Articles 6–7; UOKiK reviews guidance

Broadcast advertising adds separation, sponsorship and placement rules

Legal requirement — paraphrased

Commercial communications must be recognisable; hidden or subliminal advertising is prohibited. Advertising of healthcare services available exclusively on a doctor's referral is prohibited in the broadcasting regime. Product and provider restrictions apply in addition.

Sponsorship and product placement have separate conditions and cannot be used to bypass prohibited advertising. Have the broadcaster classify the execution and check the applicable restrictions, rather than treating a sponsorship ident as a normal ad slot.

Sources: Broadcasting Act — consolidated text, Dz.U. 2022 item 1722 · Articles 16, 16b–16c, 17 and 17a

Allow enough airtime for required spoken content

Editorial recommendation

Medicine and device warnings use different prescribed lengths; apply the relevant sector module rather than a universal health disclaimer. Include required product information clearly and assess the full voiceover, endorsement and sponsor treatment.

Recommended production check: time the final recording, listen for clarity at ordinary playback speed, and remove claims that become misleading without the visuals used in another version of the campaign.

Sources: Medicine advertising regulation — consolidated text, Dz.U. 2023 item 1648; Medical-device advertising regulation — Dz.U. 2023 item 817 · Medicine regulation section 8; device regulation section 3

Keep one campaign evidence and approval record

Editorial recommendation

Recommended workflow: record the exact offer and legal classification, advertiser, selected channel and creative formats; list permitted claims and evidence; review the Polish execution and destination; record sign-off, publication and corrections.

Keep the source date with the rule. Recheck legislation flagged as changing, especially pharmacy advertising. Preserve statutory archive periods where they apply; this suggested general workflow does not create a universal retention period.

Sources: URPL — Advertising medical devices; Sejm official API — Pharmacy advertising amendment, process 3002 · Specific retention and legislative-watch sources; workflow is editorial