Scope of the Legislation:

Medical devices used on humans as a part of diagnosis and treatment and covered by the Medical Device Regulation, and in vitro diagnostic devices used in diagnosis via analyzing sample from human and covered by the In vitro Diagnostic Medical Devices Regulation.

Basic Security Requirements:

Annex I “GENERAL SAFETY AND PERFORMANCE REQUIREMENTS” to the aforementioned Regulations is needed to be met on a benefit-risk basis.

Conformity Mark Required by the Legislation:

CE marking

Conformity Assessment Procedure Required by the Legislation:

In the case of Class I other and Class A other devices, the manufacturer, after preparing the technical documentation specified in Annex II and Annex III to the Regulations, shall declare the conformity of its products by issuing the EU declaration of conformity referred to in Article 19.

In the case of devices with a higher risk class, the manufacturer shall carry out the conformity assessment of the device in question in accordance with the relevant conformity assessment procedures set out in Annex IX to Annex XI to the Regulations.

Date of Entry Into Force:

• Regulation on Medical Device: Published in the Official Gazette dated 2/6/2021 and numbered 31499 (repeated) and entered into force on 26/05/2021.
• Regulation on In Vitro Diagnostic Medical Devices: Published in the Official Gazette dated 2/6/2021 and numbered 31499 (repeated) and entered into force on 26/05/2022.