The new article highlights the aspects related to the recalls and withdrawals initiated by the authority or by a party responsible for a medical device itself.
Table of Contents
The Turkish regulating authority in the sphere of healthcare products has recently published a guidance document dedicated to withdrawals and recalls for both general and in vitro diagnostic medical devices. The document provides an overview of the applicable regulatory requirements, as well as recommendations to be considered by the parties involved in operations with medical devices in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.
The present document constitutes the initial version of the guidance. Its scope covers, inter alia, the aspects related to the classification of nonconformity, as well as withdrawal and recall processes.
Actions Requested by the Authority
First of all, it is important to mention that special actions could be taken with respect to a medical device placed on the market by the responsible entity on its own initiative, or based on the appropriate request issued by the authority. According to the guidance, should the authority determine that the product is not in compliance with the applicable regulatory requirements (for instance, in the course of marketing surveillance activities), it will take all the steps necessary to initiate a withdrawal and recall based on the nonconformity class and risks associated with the product. In such a case, the authority will announce the withdrawal and recall decision taken on its official website, or communicate it to the parties involved in other ways it finds appropriate.
A party responsible for a medical device should, within 10 business days from the date the abovementioned notification has been issued (except otherwise explicitly stated in the appropriate decision), submit a draft plan together with the notification to the authority for review. The latter will review the drafts provided and communicate its feedback. Based on that feedback, certain changes to the plan and/or notification could be required. Once the withdrawal/recall plan and notification are agreed upon with the authority, the party responsible for a medical device should initiate the respective process to make sure the device in question is removed from the market without undue delay.
As the very first step, the party responsible for the affected medical device should issue a notification, communicating the important information to all the parties involved using the appropriate distribution channels. The consequent withdrawal/recall should be carried out without undue delay. Once all the activities set forth under the pre-approved plan are duly completed, the responsible party should notify the authority accordingly and provide the details about the results, attaching the response forms received from the parties involved. In case the affected device is being exported, the relevant national regulating authorities should be informed as well.
According to the guidance, a party responsible for a medical device shall prepare an interim report containing basic information about the actions taken and submit it to the authority within 5 business days from the date all the devices have been received. While the authority will be assessing the information submitted, the responsible party shall proceed with the following steps prescribed by the plan. Once all the actions outlined in the plan have been completed, a responsible party shall, not later than 5 business days from completion, submit a final report to the authority.
Should the authority be satisfied with the way the withdrawal or recall has been conducted, it will notify the responsible party accordingly, and the respective process will be deemed completed.
The authority additionally emphasizes that the notification described herein above should be issued for informational purposes only, hence, should not contain any adverting elements. Its sole purpose should be to communicate the information about the withdrawal/recall and the actions to be taken with respect to affected medical devices. The appropriate notifications should be shared via the general distribution channels, and also with the authority and any relevant agency. It is important to mention that in this respect, the guidelines developed by the European Commission should be followed, to the extent they do not contradict the applicable national regulations.
In cases when the party responsible for a medical device cannot be identified, the authority will handle the recall procedure itself.
The document also provides additional clarifications regarding the voluntary withdrawals and recalls – the ones conducted by the party responsible for a medical device in question at its own initiative. As explained by the authority, the responsible party conducts risk-based studies with respect to medical devices for which reasonable suspicions of non-compliance are in place as a part of post-market surveillance activities. Based on the results of such an assessment, a decision to withdraw the non-compliant medical device could be taken.
As in the case of forced withdrawals and recalls, the procedure for the ones conducted voluntarily begins with the party responsible for a medical device submitting a draft plan and notification to the authority for review. Should the decision taken be related to a medical device imported to the country, the responsible party shall notify the authority about such a decision within 5 business days, except for force majeure events. The same reporting timeframe applies to notifying the authority about the completion of the actions taken.
In summary, the present guidance describes in detail the aspects related to both forced and voluntary withdrawals and recalls. The document outlines the main steps to be taken, and also highlights the key points to be considered when initiating and commencing the process.
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