Turkey: TITCK Updates the Removal and Recall Guidelines for Medical Devices and IVDs

Due to the amendment of Paragraph 8 of Article 16 in Product Safety and Technical Regulations Law, No. 7223, the Turkish Medicines and Medical Device Agency (TITCK) has revised the guideline for the removal and recall of medical devices and in-vitro diagnostic devices.

This scope is involving 2 responsible parties which are the Institutions (TITCK) and the Economic Operators.

1) TITCK:

• Notify the economic operators of the measures taken, administrative reasons, and solutions for the withdrawal or recall actions

• Ensure the measures taken to withdraw or recall all the necessary risky medical devices

• Announces the withdrawal or recall of the medical devices that are directly addressed to the consumers via the Product Tracking System (ÜTS)

• Informs the notified body that issuing the certificate for the device, if the device potentially carries high risk.

2)Economic Operators

• Conduct risk-based studies for medical devices suspected to be noncompliance or non-conforming

• Notify and inform about the withdrawal or recall actions to the Authority, the TITCK, or the EU-authorized body if the devices have been supplied to the EU market

• Provide all documentation requested by the Authority for the withdrawal or recall procedures within the periods given

• Ensuring all the non-compliance medical devices have been removed or recalled from the market according to the provisions effectively

The withdrawal or recall of medical devices from the market is according to the classification of the non-conformity of the devices. Other than that, the choice to withdraw or be recalled might be made voluntarily or through the TITCK.

Withdrawal and Recall Actions Based on Voluntary Market

The voluntary decision is made after the risk-based studies carried out by the economic operator on the suspected noncompliance devices. Voluntary withdrawal or recall must be decided according to the provisions.

The responsible economic operator should submit the plan and notification of the withdrawal or recall to the agency. For withdrawal or recall of devices imported from countries abroad, the economic operator should inform the authority within 5 business days of the notification. While informing TITCK of the decision should be made within 5 business days after the completion of the action.

Withdrawal and Recall Actions Based on Decisions from the TITCK

Once the suspected medical devices are determined by the authority as non-conforming devices, the decisions of withdrawal or recall must be made according to the non-compliance class and the risk class of the devices.

TITCK would announce the withdrawal or recall decisions on the website and perform necessary actions on ÜTS.

Here, the responsible economic operators would play a major role in:

• submitting the plan and notification of the decision to the authority within 10 working days

• After the evaluation by the Authority, the economic operators will initiate the plan, convey the withdrawal or recall notification to all distribution channels within 10 working days, and inform the concerned authority if the devices have been exported abroad.

• Notifying the related Notified Body if the withdrawn or recalled devices carry serious risk

• Within 5 working days following the receipt of all withdrawn or recalled devices, the responsible economic operators must prepare an interim report (Annex 2)

• Carry out the proposed activities for the withdrawn or recalled devices after interim report evaluation by the Authority

• Upon completion of the activities planned for the devices, the final report should be submitted to the Authority within 5 working days

• The process of withdrawal or recall of the risky medical devices would be concluded as complete once the Authority satisfied with the whole procedure

While for any cases that happen with no provisions provided in the guideline, the Framework Regulation on Market Surveillance and Inspection of Products (No 31537) and Provisions in the Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation (No 31499) shall apply.

Source: Turkish Medicines and Medical Devices Agency (TITCK)