EU-IMPORTER-AS-A-SERVICE
In our role as importer for non-EU manufacturers, we take on the task and responsibility of placing a medical device on the EU market.
Placing your medical device on the EU market
Among economic operators, only manufacturers and importers place devices on the market – and therefore have the ultimate responsibility that only safe and compliant devices do so.
After successfully passing the conformity assessment procedure, manufacturers located in the EU bring their devices to the market themselves. However, the importer according to Article 13 of the MDR or IVDR, respectively, takes on this part for non-EU manufacturers.
We take on this function – and responsibility – for you
For placing your device on the European market, THE FORCE verifies your device has been CE marked and registered within the EUDAMED database, and that the EU declaration of conformity is available. Also, we ensure your device is labelled in accordance with the MDR/IVDR, including the identification of the manufacturer, and is accompanied by the required instructions for use.
While under our responsibility, our team assures appropriate storage and transport conditions as well as proper handling of your device to maintain compliance with all general safety and performance requirements.
We not only guarantee a fluid communication between all economic operators, competent authorities, and notified bodies, but also participate in post-market surveillance activities for your device to ensure that necessary corrective actions are taken wherever needed.
