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Medical device advertising part 2.


 

🔸Did you know that advertising of a medical device to medical professionals is not only a message during congresses, visits to doctors, pharmacists and other medical professionals, but advertising can also be a justification for a question asked in a tender?

 

🔸Advertising of a medical device is any information that serves to encourage the purchase or use of a medical device, so it may be that advertising of a medical device will be included in the justification of a question asked during a tender to the Terms of Reference for clarification of its content by indicating 'does the contracting authority require that the medical device to be procured has' ... (the characteristics specified in this question).

 

🔸In any event, it should be borne in mind that, in accordance with Article 7 of Regulation (EU) 2017/745 of the European Parliament and of the Council, it is prohibited, in the labelling, instructions for use, making available, putting into use and advertising of devices, to use texts, names, trademarks, pictures and symbols or other signs likely to mislead the user as to the intended use, safety and performance of the device by:

1. ascribing to the product functions and characteristics which the product does not possess;

2. giving a false impression of a treatment or diagnosis, function or characteristic that the device does not have;

3. failing to inform the user of the probable risks associated with the use of the device in accordance with its intended use;

4. suggesting uses of the device other than those stated to be part of the intended use for which conformity assessment has been carried out.

 

🔸In addition, it should be borne in mind that promotional materials, presentations and information on medical devices must not be misleading with regard to the characteristics and performance of the device.

 

🔸A medical device distributor preparing its own information materials on the basis of catalogues, product data sheets and other materials provided by the medical device manufacturer must include complete and true information about the name, characteristics and use of the medical device in the material.

 

🔸At the same time, it is worth remembering that advertising of a medical device does not constitute:

1. a trade catalogue or price list containing only the trade name, the price of the device or the technical specification;

2. information placed on the packaging and attached to the packaging of the devices, in accordance with the provisions of the Act and Regulation 2017/745 or Regulation 2017/746.

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