Advertising and Promotion Requirements for Medical Devices in Finland

1. Overview

Marketing (advertising and promotion) of medical devices influences usage, user identification, purchase decisions, and patient safety. Materials must be truthful, non-deceptive, include relevant device information and intended purpose, and target appropriate users. Source: Fimea Marketing of Medical Devices Page https://fimea.fi/en/medical-devices/marketing-of-medical-devices

2. Prohibited Claims

Under MDR Article 7, IVDR Article 7, and Finnish Medical Devices Act Section 10, marketing (including labelling, instructions, availability, and advertising via text, images, etc.) must not:

• Ascribe non-existent functions or properties.
• Create false impressions about treatment, diagnosis, functions, or properties.
• Omit likely risks associated with intended use.
• Suggest uses outside the conformity-assessed intended purpose. Source: Fimea Marketing of Medical Devices Page https://fimea.fi/en/medical-devices/marketing-of-medical-devices

3. Required Information in Marketing Material

Marketing must clearly indicate:

• The manufacturer.
• The trade/brand name.
• That the product is a CE-marked medical device.
• Notified body number (if certificate required). Non-medical devices cannot be presented as medical devices. Non-CE-marked devices cannot be marketed in the EU (except developmental devices, clearly stating non-CE status and unavailability). Source: Fimea Marketing of Medical Devices Page https://fimea.fi/en/medical-devices/marketing-of-medical-devices

4. Tips for Compliant Marketing

• Confirm the product is a medical device (not medicine or cosmetic).
• Include CE marking statement and notified body number if applicable.
• State intended use clearly, including environment and limitations.
• Target correct user group (e.g., avoid promoting professional devices for lay use).
• Ensure claims align with manufacturer's intended purpose. Source: Fimea Marketing of Medical Devices Page https://fimea.fi/en/medical-devices/marketing-of-medical-devices

5. Q&A Highlights

• Promotional materials include print, digital, presentations, websites, influencer content.
• Cannot claim approval by authorities like Fimea.
• Custom-made devices/systems: State as medical device but not CE-marked.
• Contests/giveaways/samples: Permitted if compliant with regulations (including Consumer Protection Act).
• Influencer marketing: Allowed if truthful and targeted correctly. Source: Fimea Marketing of Medical Devices Page https://fimea.fi/en/medical-devices/marketing-of-medical-devices