Marketing of medical devices

Marketing of medical devices, teksti

The marketing for medical devices guides, how the devices are to be used and for whom the device is intended. Thus, appropriate marketing of medical devices plays an important role in guiding purchase decisions and accordingly, promoting patient safety.

Consequently, the marketing material for medical devices should:

be truthful, without deceptive claims,
contain the relevant information of the medical device and the intended purpose,
target the right user group.

On these pages you will find information on requirements for marketing claims for medical devices, what information should be given in the marketing material, and tips for the successful marketing of medical devices. At the end, you will find links to legislation that regulates the marketing of medical devices.

Marketing of medical devices

Marketing claims for medical devices must describe the actual properties and purpose of the device.

In the labelling, instructions for use, making the devices available, putting them into service, and advertising, using text, names, trademarks, images, and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance is prohibited.

In short, marketing must not
- ascribe functions and properties to the device which the device does not have,
- create a false impression regarding treatment or diagnosis, functions, or properties which the device does not have,
- fail to inform the user or the patient of a risk associated with the use of the device in line with its intended purpose,
- suggest that the device may have uses other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
The marketing information must indicate the manufacturer of the device and the trade name or brand name given by the manufacturer, and that the product is a CE-marked medical device. If a certificate by a notified body is required for the device, marketing shall further state the number of the notified body that issued the certificate. A device which is not a medical device may not be claimed to be a medical device in marketing material.
A medical device that is not CE marked may not be marketed in the EU. Medical devices that are still under development are exempted from this rue and they may be marketed in advance. In such a situation, the marketing must clearly state that the device is not yet CE-marked and that it is not yet available.
First, check if the regulation of marketing medical devices is applicable to the product in question: is the product to be marketed a medical device, or is it a medicine, or a cosmetic product instead?

If the product to be marketed is a medical device, consider at least the following aspects in your marketing material:
1. Indicate that the device to be marketed is a ‘CE-marked medical device’. Also, do not forget to give the number of the notified body, if the device has such a number.
2. Mention the manufacturer of the device and the brand name or trade name given by the manufacturer.
3. Make sure that the intended use of the product is clearly stated. The user must be capable of identifying the intended use of the device and to act accordingly. In addition to the intended use, describe the environment in which the device is to be used, in addition to any possible constraints.
4. Aim your marketing at a user group that corresponds to the intended use. Do not promote a device intended for adults as something that can be used by children, or a test intended for professionals as a home test.
5. Check that the marketing material does not contain misleading claims. The claims and the advertising slogans should guide the user to follow the guidelines for intended use set by the manufacturer.
The marketing of medical devices is controlled both by EU regulations and national legislation.
Claims made of medical devices:
- MD Regulation, (EU) 2017/745, article 7
- IVD Regulation, (EU) 2017/746, article 7
National regulations on marketing medical devices:
- Medical Devices Act 719/2021, section 10
The links and more information can be found from the following webpage: Legislation related to medical devices.

Marketing of medical devices, Q&A

Marketing of medical devices - Questions and Answers

Marketing of medical devices, kysymykset ja vastaukset 2

Promotional material can come in many formats. For example, it can be printed material, audio, a video commercial, an email or other visual or verbal presentation. Promotional materials can therefore include press releases, websites, brochures, abstracts, scientific posters, placards, publications and video presentations. Marketing requirements must also be considered in the product information presented in influencer marketing and public procurement competitions.
It is not forbidden to use the term ‘marketer’ in marketing material. However, instead of ‘marketer’, the use of terms contained in the legislation, such as manufacturer, importer, or distributor is recommended. Of these three actors, the information of the manufacturer should always be indicated in the marketing material.
There is no official approval or market approval process for medical devices. Thus, claims such as ‘Device approved by Fimea’, or ‘Test approved by the Authority’ are not permitted.

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