Call to us 22 826 00 75
22 212 87 64 Contact form
Quick contact

A computer program can be considered as a medical device that is helpful with prescribing medicines

Software supporting  medicines prescribing (for eg. during resuscitation and anesthesia as contraindications, interactions with other medications, or excessive dosing) may be considered as a medical device. The only requirement would be obtaining the CE marking.

The syndicat de l'industrie des technologies médicales (French organization bringing together medical device manufacturers) questioned thelegal provision of a decree ordering that any program that would assist doctors in attributing drugs to patients is a subject of mandatory certification (pursuant to French national law). The complainants argued that the EU directive 93/42 on medical devices should be sufficient to obtain the CE marking without having to comply with the additional requirements of national law.

The French court against which this legal provision was challenged raised a question for a preliminary ruling to the Court of Justice of the European Union, which stated that computer software supporting the attribution of medicines could be regarded as a medical device, which means the right to sell freely after obtaining the CE marking.