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.

In case a medical device is classified under several classes due to its numerous intended purposes, the applicable higher risk class would be taken into consideration. For instance, under the MDR, an invasive device that is intended for temporary use falls within Class I, whereas a surgical invasive device (i.e. an invasive device that is intended to be used in surgeries) is classified as Class IIa due to the level of risk it poses and the additional intended purpose of usage. In case a surgical invasive device can further be used in surgeries through direct contact with the heart, central circulatory system or central nervous system, it is classified as a Class III. Such a surgical medical device would be concluded as Class III in light of the above. Devices within higher risk classes are subject to closer scrutiny under the legislation.

Placing of medical devices on the market and related obligations. Medical devices may be placed on the market provided that they are duly supplied, properly installed, maintained and used in accordance with their intended purpose. Applicable marketing rules and obligations of "economic operators" (which refer to manufacturers, authorised representatives, importers and distributors of medical devices) are determined based on the classification of the relevant medical device. Main obligations of economic operators under the MDR and IVDR are as follows:

Economic operators must

  • ensure that the medical device carries a CE marking and EU conformity declaration before it is marketed. The EU conformity declaration includes (i) information pertaining to the economic operator, (ii) indicators regarding the traceability of the economic operator (Basic UDI-DI, which is a device identifier specific to the manufacturer and the device providing access to the information and the certificate) and (iii) the risk class of the device.
  • carry out a conformity assessment in order to place a medical device on the market, which certifies the medical device's compliance with the legislation. The conformity assessment of low-risk class medical devices are under the responsibility of the manufacturer, whereas conformity assessment of medical devices with higher risk classes require the involvement and assessment of third parties (i.e., the so-called notified bodies).
  • develop, document, implement and maintain a quality management system and post-market surveillance plan as per the class of the medical device. Besides, the manufacturer is required to carry out post-marketing surveillance in cooperation with the other economic operators to collect and review the data concerning the medical device that they place on the market. This is carried out through a system to be established by the manufacturer according to the risk class of the medical device. The purpose here is to identify any necessary corrective or preventive actions required for the medical device. As part of the post-marketing surveillance, certain reports should be submitted to the Authority in order to demonstrate continued compliance with the MDR or IVDR. In this context, post-marketing surveillance reports should be prepared and submitted to the Authority for Class I medical devices and Class A and B in vitro diagnostic medical devices, and shall be updated when necessary and a periodic safety update report should be prepared and submitted to the Authority for higher risk classes such as Class IIa, IIb and III medical devices and Class C and D in vitro medical devices, and shall be updated at least annually.

In addition to the above, manufacturers are obliged to carry out vigilance activities such as reporting adverse events to the Authority and taking corrective measures for site security. They should also employ a compliance officer who shall be responsible for the inspection of the quality of the device through quality management systems and ensuring compliance with the legislation.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.