On May 26, 2021, the Medical Device Regulation (MDR) of the European Union became binding, bringing changes for all manufacturers of medical products. But what exactly do these new regulations entail?
The MDR represents a new regulation of medical devices by placing a stronger emphasis on safety, quality, and transparency. The goal is to further enhance patient safety and make the entire lifecycle of medical devices safer and more transparent. These values are achieved through stricter requirements for the clinical evaluation of medical devices. Manufacturers must now conduct even more thorough testing and monitoring of their products to demonstrate safety and performance.
The MDR introduces far-reaching changes aimed at improving the safety, quality, and transparency of medical devices. This enhances trust in the safety and efficacy of medical products.
As a manufacturer, it is our priority to continue providing our customers with safe medical devices. Therefore, we are actively working towards certification in accordance with the requirements of the Medical Device Regulation (MDR).
If you have any questions on this matter or require further information, please do not hesitate to contact us. We are at your disposal and happy to assist you.
