How to sell and advertise medical devices

Selling and advertising medical devices

Since June 19, 2023, sellers have been obliged to correctly classify a product as a medical device. See how to legally sell and advertise medical devices on Allegro.

1. Check the applicable legal acts before you start selling medical devices.

Before you start selling medical devices, check the regulations — including those regarding the distributor's obligations — set forth in:

• the Act of April 7, 2022, on medical devices (available in Polish)
• the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
• the Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices.

2. Verify whether you offer medical devices, and mark them.

How to do it?

• Check the documentation (for example, the EU declaration of conformity for a given device).
• Contact the manufacturer or importer.

A medical device may be any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used for human beings for specific medical purposes (for example for diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease), and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. For example tourniquets, bandages and gauze, wheelchairs, orthoses and orthopedic corsets, dental floss, scalpels and surgical forceps, pulse oximeters, thermometers, glucometers and blood pressure monitors, corrective glasses and hearing aids, condoms, contact lenses, AED defibrillators.

In vitro diagnostic medical devices are a special type of medical devices.

A special type of medical devices are in vitro diagnostic products.

Parameter: Medical device

The Medical device parameter is obligatory in select categories (available in Polish). Complete it while listing the offer or use the Add Parameters tab. This will help us make sure exactly what products you sell and whether you do it according to the law.

What happens if you fail to complete the obligatory parameter

In that case:

• you will not list new offers
• you will not edit ongoing offers
• you will not relist offers.

Complete the Medical device parameter in offers where you sell medical devices within the meaning of the Act of April 7, 2022, on medical devices:

• medical devices, medical devices equipment, and products listed in Annex XVI to the Regulation (EU) 2017/745 of the European Parliament and of the Council
• in vitro diagnostic medical devices and in vitro diagnostic medical devices equipment mentioned in the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.

3. Check whether offer descriptions are compliant with the new regulations.

How to do it?

If you sell a medical device on Allegro, we require you to:

• complete the Medical device parameter
• include the following information in the description:

• the CE marking
• the 4-digit notified body number (if it participated in the procedure to assess the product's conformity)
• information about the marking, label, and user interface in Polish
• a manual in Polish
• information about the EU declaration of conformity, unless there are exceptions set forth in the Act of April 7, 2022, on medical devices.

If you sell products for self-testing (listed in Article 2 (5) of the Regulation 2017/746), the description should also contain a note that the packaging (label) and user manual clearly inform about such purpose of the product.

Remember that the offer cannot contain text, names, trademarks, images, symbols, or other signs that may mislead about the product's intended use, safety, or functioning.

4. Submit an approval to advertise and promote medical devices

If you sell medical devices on Allegro and want to advertise them using the tools we provide (for example, Allegro Ads) — by the provision of the Act on medical devices, we require you to submit written approval of advertising activities.

How to do it?

Download the declaration, complete it with your details, and send it to the following address with a text medical devices.

Allegro sp. z o.o.

ul. Żelazna 51/53

00-841 Warszawa

Seller's declaration — advertising medical devices

Do not delay sending the declaration — it may take us several days to verify it. We will let you know whether the verification has been successful.

What if you use the services of a third party to advertise your products

If you outsource advertising activities to other entities, for example, an advertising or media agency that uses our promotional tools — they can provide us with the declaration on your behalf. However, you must give them a power of attorney that includes the authority to make such a declaration. We may then ask you or the entity you cooperate with to produce it.

How to do it?

The agency should download the declaration (the template is available below), complete it with their details, and send it to the following address with a text medical devices.

Allegro sp. z o.o.

ul. Żelazna 51/53

00-841 Warszawa

Agency declaration — advertising medical devices

Check the Allegro Terms & Conditions for more details

Since June 19, 2023, sellers have been obliged to correctly classify a product as a medical device. If a seller fails to do that (for example, by not completing the Medical device parameter), we reserve the right to assert claims against them in connection with the damage suffered.

If you sell medical devices, you become their distributor. Therefore, you have certain responsibilities, which are listed in the Act on medical devices and both EU regulations. As the medical device distributor you must be aware that the products you sell are medical devices.

If you want to advertise medical devices, remember that both the Act on medical devices and the regulation of April 21, 2023, of the Minister of Health on advertising medical devices specify the rules for advertising such products. Those legal acts specify, for example, what information should such an advertisement contain (including the entity in charge of the advertisement, the name of the manufacturer or its authorized representative, and warnings). Bear in mind that medical devices should be advertised in line with those requirements.

Marking the medical devices' advertisements

According to the European Union regulation — the Digital Services Act — starting February 17, 2024, we additionally mark the advertisements on our platform. That means we will mark the advertisements of medical devices with the markings Sponsored, Promoted, or Contains promotions. In addition, we will add the Medical device badge to it.

We will also display:

• the advertising entity
• the manufacturer's name
• the authorized representative — if their name is provided in the offer
• the warning concerning the use of different types of medical devices.