The Turkish Medicines and Medical Devices Agency (TMMDA) is the Regulatory Agency/Health Authority (HA) of the Government of Turkey. It acts as the Regulatory authority for medicines, medical devices, health products, personal care products, and cosmetics in Turkey. Recently, the TMMDA has published a guidance document dedicated to withdrawals and recalls of both general and in vitro diagnostics. It provides an overview of the applicable Regulatory requirements and the recommendations to be considered by manufacturers, healthcare institutions, and other parties involved in medical device operations to ensure their safety and efficacy.

To comply with the Regulatory requirements, the TMMDA outlines a set of responsibilities of various parties involved in medical device operations, with respect to withdrawals and recalls.

Responsibilities of Economic Operators (EOs) and Other Parties

• Ensuring the efficacy of the withdrawal process and performing voluntary withdrawals to protect public health and patient safety.
• Developing and executing a withdrawal plan and notifying the TMMDA if a withdrawal is initiated by the latter.
• Notifying the TMMDA if an affected device has been placed on the European Union (EU) market. In addition, the agency responsible for the certification of the affected medical device should be notified about the associated risks.
• Providing all the information and documentation related to the affected devices and actions taken during a withdrawal, when requested by the TMMDA.
• Carrying out all obligations related to Post-market Surveillance (PMS), such as development, implementation, and execution of appropriate procedures.

If a withdrawal has begun, and if the EO is involved in the storage, distribution, sale, and use of medical devices, their responsibilities include:

• Stopping the services (marketing) and use of the withdrawn devices and initiating the necessary actions immediately.
• Contacting the places where the withdrawn devices have been distributed.
• Maintaining all records related to the withdrawal and making them available, when requested by the authority.
• Forwarding the withdrawn device to the next supply chain for initiating the return process and filling in the response form in line with the notification for withdrawal from the market/recall notification.

Responsibilities of Healthcare Institutions

• Notifying the regulating authority, other parties, and certifying agencies about the withdrawal decisions, in case of a high-risk device.
• Announcing the withdrawal and recall actions in a proper way, beyond publications/announcements on the website.
• Performing continual risk assessments to ensure that the risks of the device are within the acceptable level.
• Monitoring the proper execution and actual efficacy of the initiated withdrawals and recalls with respect to the medical devices used.
• Documenting the procedures, keeping records, and providing the necessary documents when the authority asks for them.

The TMMDA also describes the approachable ways to classify nonconformities associated with medical devices. Nonconformities can be categorized into the following three (03) classes:

• First Class: Nonconformities that pose serious risks associated with the device in question and that may result in a temporary or permanent serious deterioration in patients’ health status or pose a serious public health threat.
• Second Class: Device-related nonconformities that cause or may cause temporary and curable deterioration in the health of the patient, user, or another individual.
• Third Class: Nonconformities that are contrary to the provisions of the technical regulations other than product safety.

The above classification would impact the approach towards withdrawals and recalls in the following two (02) ways:

• Withdrawals and recalls apply for first-class nonconformities.
• Withdrawal from the market applies for second- and third-class nonconformities.

As per the guidance document, the withdrawal and recall process involves the following stages:

• If the device does not comply with the Regulatory requirements, the TMMDA will take the necessary steps to initiate a withdrawal and recall, depending upon the nonconformity class and risks associated with the device.
• The TMMDA will announce the decision of withdrawal and recall on its official website or communicate it to the involved parties.
• The parties involved should submit a draft plan, together with the notification for the authority review, within ten (10) days from the date of issuing the notification.
• The TMMDA will review the drafts and communicate their feedback on it. They could suggest changes to the plan or notification.
• Once the TMMDA agrees on the withdrawal and recall plan and notification, the party responsible for the medical device should initiate the respective process(es) and ensure that the affected device is removed from the market without undue delay.

Conclusion

In conclusion, the guidance document outlines the specific Regulatory requirements and the responsibilities of various parties involved in medical device operations, with respect to withdrawals and recalls. Additionally, it highlights the classification of nonconformities and key points of the withdrawal and recall process.

Is your medical device in a situation of withdrawal or recall? Do you want to ensure compliance with the TMMDA Regulatory requirements? Contact Freyr – a proven Regulatory solutions and services provider. Stay informed! Stay compliant!