What you need to know about the new medical devices regulation

What is the new medical devices regulation (MDR)? The MDR covers practically all relevant aspects for the licensing and production of medical and medical technology devices. The most important thing here is that all manufacturers need to establish a risk and quality management system and to have it audited. The MDR assigns all devices to risk classes. For example, pacemakers and artificial knee joints are assigned to class III, the most critical. Depending on the risk classes of their products, manufacturers must define specific production, quality assurance, and recall processes. It means that all products must be traceable, the tools, machines, and processes used for the production of these devices and the results achieved must all be documented. Among other requirements, the regulation states that each individual device must be unambiguously identified, for example by a barcode.