Aymaneh
Starting to get Involved
Hello, we are a company that assembles medical devices into a system pack, as defined in Article 22 of MDR 2017/745. Additionally, we are considered a distributor because we make the system, which incorporates these medical devices, available on the market and put it into service. We do not directly purchase these medical devices from the manufacturer; instead, we go through a supplier who provides these medical devices to us. In this context, is our supplier also considered a distributor, and are they required to meet the requirements outlined in Article 14 of MDR 2017/745? What are the implications if our supplier does not comply with some of these requirements? Despite this, we are in the process of establishing our own procedures to ensure compliance with the obligations detailed in Article 14 of MDR 2017/745.
