Medical Devices Regulation (MDR) and Medical Devices Directive (MDD) Medical devices manufactured or traded in Europe must comply with EU legislation in the field of safety or health.. This means that they comply with the relevant product directives and receive the CE mark.
First of all, let’s start this article by answering that question that we all have: Where did this Regulation come from? Let’s take the calendar back a little. It is understood that there are “industrial silicone” in millions of breast prostheses put on the market by a company called “PIP”, a famous breast prosthesis company in France. Then, of course, it is the beginning of a process that ends in disaster. Notified bodies, company executives, suppliers and perhaps many businesses are beginning to be questioned about product safety over this issue. For this reason, the European Union decides to prepare a Regulation in which notified bodies are also more liable in order to ensure product safety and to monitor medical devices more closely. In other words, the main purpose is to ensure the safe supply of products in healthcare.
There are many responsibilities under the MDR that concern importing companies. MDR is a regulation that is difficult to implement and has many responsibilities, but must be implemented. As Suno Medical, we support and use this regulation. As Suno Medical, we always care about the customer health and the customer. With our structure that does not compromise on quality, we always try to raise the quality to the highest level. We are extremely proud to say that we are also very committed to the MDR regulation and working with MDR.