By email of 20 November 2017, the Belgian authorities notified the Commission of their decision of 28 October 2016 to prohibit the placing on the market, putting into service, distribution and importation of the Terrafor medical device, and to order the withdrawal of the device from the market.
La directive 93/42/CEE établit un système par lequel les dispositifs médicaux doivent satisfaire aux exigences essentielles figurant à l'annexe I de la directive qui leur sont applicables (article 3, premier alinéa).