| Abstract (english) | 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outdated.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. |
