Classification of Medical Devices and Placing the Same on the Market

Our latest article “Classification of Medical Devices and Placing the Same on the Market” by Nihan Bacanak, Zeynep Toma and Selen Toma is published on Mondaq.

Medical Device Regulation (the “MDR“) and In Vitro Diagnostic Medical Device Regulation (the “IVDR“), as adopted by the Turkish Medicine and Medical Devices Authority (“Authority“) are the main pieces of legislation in Turkey in relation to medical devices. With an effort to align with the EU standards, the provisions of MDR and IVDR mostly mirror the provisions of Medical Devices Regulation numbered 2017/475 and In Vitro Diagnostic Medical Devices Regulation numbered 2017/746 of the European Union.

Medical devices are classified in two main categories under the Turkish medical devices legislation: (i) medical devices and (ii) in vitro diagnostic medical devices. There are a number of sub-categories under the MDR such as invasive, non-invasive, custom-made, active, investigational, implantable medical devices. Certain products that may be considered as non-medical per se such as contact lenses, cosmetic implant devices, liposuction equipment, lasers and brain stimulation equipment are also included within the scope of the MDR, and are thus subject to the related medical devices legislation.

Classification. Medical devices are classified on a risk-basis approach under (i) Classes I, IIa, IIb and III for medical devices, and (ii) A, B, C and D for in vitro diagnostic medical devices from the lowest to the highest risk group. The risk classes are determined based on the intended usage purpose of the medical device and the risks that the medical device entails due to its nature and complexity.

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