MDR Process in Medical Devices
MDR is the name given to the practices know as Medical Device Regulations as a whole. This practice, which entered into force on May 25, 2017, is an arrangement introduced within the scope of reassessment of medical devices although their compliance has been certified before. This arrangement aims at determining the compliance of medical devices with the new system.
It covers compliance in medical devices relating to equipment produced in the European Union under the MDR process or set to sale in this region. Compliance thereof with the legislation and closeness thereof to meeting the safety standards are handled in this framework. Solutions are being developed relating to MDR, which is also necessary for obtaining a CE sign and Declaration of Conformity.
How is the course of proceeding under MDR?
In order to ensure compliance of medical devices, the producing firm has to make an application and receive consultancy services from the accredited institution first. Compliance with MDR is assessed after the required tests and controls. A certificate is issued for the medical devices under MDR when the deficiencies are overcome and the controls are done. In this way, circulation of the products within the borders of the European Union becomes possible.
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