Class I devices
As the COVID pandemic became global, many businesses in Hungary wanted to participate in the defense, including manufacturers who have not previously had experience in medical device production. These manufacturers have typically focused on creating such devices that can contribute effectively to the defense, but the manufacturing technology is not particularly complex and does not involve any outstanding risks (Class I, simple, well-established devices). Examples of such devices are single-use surgical masks or infusion and/or intensive care stands. Despite the simplicity of the devices, these new manufacturers must also fully comply with the general requirements in accordance with the MDR. In many cases, manufacturers of these devices came from areas that did not have a direct connection to medical technology (textile or paper industry, metal industry, etc.), thus these manufacturers needed expert assistance to cope with the regulatory environment unknown to them.
In our fictitious example, we provided advisory services to a manufacturer that had not previously manufactured a medical device, but because of COVID, it started to manufacture single-use surgical masks and asked us to compile the technical documentation. During the project, it became more and more obvious to the manufacturer that, although the device is simple, many obstacles must be overcome before the device can be legally introduced to the market, ranging from the introduction of quality and risk management systems, biocompatibility and other product-specific standard tests related to the device, as well as the presentation of clinical data and the preparation of an appropriate PMS plan. After the accomplishment of these tasks, among other things, our client legally produces and sells surgical masks for today in the EU.