the withdrawal and recall of medical devices and in vitro diagnostic medical devices from the market, as well as the responsibilities, authorities, and duties of the Institution, economic operators, and other public institutions and organizations within this scope.

Introduction

The withdrawal and recall of medical devices and in vitro diagnostic medical devices from the market is a critical process to ensure the safety of patients and users. This article will discuss the purpose, scope, basis, definitions, and procedures of the withdrawal and recall process in Turkey.

Purpose

The purpose of the withdrawal and recall process is to remove devices from the market that pose a risk to patients and users. This process can be initiated by the responsible economic operator, the Institution, or a third party.

Scope

The withdrawal and recall process covers all medical devices and in vitro diagnostic medical devices that are placed on the market in Turkey. This includes devices that are imported, distributed, or used in Turkey.

Basis

The withdrawal and recall process is based on the Law on Product Safety and Technical Regulations, the Framework Regulation on Market Surveillance and Inspection of Products, and the Medical Devices Regulation.

Definitions

The following definitions are important to understand the withdrawal and recall process:

  • Device: A medical device or in vitro diagnostic medical device that is placed on the market in Turkey.
  • Responsible economic operator: The manufacturer, importer, or distributor of a device that is placed on the market in Turkey.
  • Institution: The Turkish Medicines and Medical Devices Agency.
  • Risk: The likelihood of a hazard occurring and the severity of the potential harm from that hazard.
  • Recall: A measure aimed at retrieving a device held by the end-user from the responsible economic operator.
  • Withdrawal: A measure aimed at preventing the placing on the market of a device in the supply chain.

Procedures

The withdrawal and recall process can be initiated by the responsible economic operator, the Institution, or a third party. The process typically involves the following steps:

  1. The responsible economic operator or the Institution identifies a device that poses a risk.
  2. The responsible economic operator or the Institution assesses the risk and determines whether a recall is necessary.
  3. If a recall is necessary, the responsible economic operator or the Institution notifies the Institution and other relevant stakeholders.
  4. The responsible economic operator or the Institution implements the recall plan.
  5. The responsible economic operator or the Institution monitors the recall process and reports to the Institution on the progress of the recall.

Responsibilities, Authorities, and Duties

The Institution, responsible economic operators, and other public institutions and organizations have different responsibilities, authorities, and duties in the withdrawal and recall process. These are summarized below:

  • Institution: The Institution is responsible for ensuring the safety of medical devices and in vitro diagnostic medical devices in Turkey. The Institution has the authority to initiate a recall, order a recall, or monitor a recall.
  • Responsible economic operator: The responsible economic operator is responsible for the safety of the devices that it places on the market. The responsible economic operator has the duty to notify the Institution of any risks associated with its devices and to implement a recall plan if necessary.
  • Other public institutions and organizations: Other public institutions and organizations, such as health institutions and hospitals, may also have a role to play in the withdrawal and recall process. These organizations may be responsible for notifying the Institution of risks associated with devices, or for implementing the recall plan.

Conclusion

The withdrawal and recall of medical devices and in vitro diagnostic medical devices is a critical process to ensure the safety of patients and users. This article has discussed the purpose, scope, basis, definitions, procedures, responsibilities, authorities, and duties of the withdrawal and recall process in Turkey.