Medical device (according to Article 3 of the Medical Devices Act, Official Gazette, No. 76/13) (1) is an instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its, for diagnostic or therapeutic procedures. Unlike drugs, medical devices do not achieve action by pharmacological, immune or metabolic effect on the body. Their purpose is mainly manifested in mechanical action, the creation of a physical barrier and the replacement or support of the role of an organ or bodily function. Medical devices include a whole range of different products whose purpose must be recognizably defined. According to risk medical devices are divided into 4 risk classes. Medical devices were regulated by MDD that came into law in 1992, and is therefore outdated. For example, Software as a Medical Device (SaMD) did not yet exist in 1992. furthermore, apps that patients used to monitor their own health did not yet exist. Therefore, on 26 May, 202 1, the Medical Device Directive (MDD) was replaced by the new Medical Device Regulation (MDR). MDR is designed to be an improved version of MDD, with the major difference being that MDR influences and provides effectiveness to all EU member states. This allows MDR to provide a regulation which is consistent and fair to all member states, increasing the standards on quality and safety measures. Not only will the MDR widen to include all 27 EU member states (excluding the UK), but the guidelines included will also urge companies to undertake action and improve on their current product hygiene and safety, thus vastly improving their overall standards.