The new article provides an overview of the recent changes to the classification rules for active implantable medical devices.
Table of Contents
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the reclassification of active implantable medical devices (AIMD). The document describes in detail transitional arrangements, as well as obligations of the parties involved associated thereto. It is also important to mention that provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications and recommendations to be considered by medical device manufacturers in order to ensure compliance with the applicable regulatory requirements. 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 legislation.
First of all, the authority states that from 25 November 2021 active implantable medical devices are required to be reclassified from Class AIMD to Class III.
It is further mentioned that the public consultations on the matter were initially conducted by the authority earlier in 2019. The changes suggested by the TGA are intended to align the national regulatory requirements with the respective EU regulatory framework. The results of the consultations demonstrated that the alignment suggested will be supported by the industry, however, there are different positions with respect to the regulatory status of accessories to AIMDs.
The authority additionally emphasizes that since the conformity assessment procedures Class III medical devices are subject to are identical to the ones that apply to Class AIMD products, the reclassification will not result in additional regulatory scrutiny.
The document further provides a definition of an active implantable medical device. As set forth in the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), active implantable medical device or AIMD means an active medical device, other than an implantable medical device, that is intended by the manufacturer:
- To be, by surgical or medical intervention, introduced wholly, or partially, into the body of a human being; or
- To be, by medical intervention, introduced into a natural orifice in the body of a human being; and
- To remain in place after the procedure.
Starting from November 25, 2021, all such products are to be classified as Class III medical devices. Examples of such devices include, inter alia, implantable cardiac pacemakers, implantable cardioverter-defibrillators (ICD), and spinal cord stimulation systems.
Apart from outlining the scope of products subject to reclassification, the document also describes the steps to be taken by the parties responsible for medical devices subject to reclassification in order to ensure compliance with the new requirements. According to the document, these steps will depend on the status of the device as of November 25, 2021. In particular, it should be taken into consideration whether the device in question was included in the Australian register of therapeutic goods (ARTG), the country’s register of healthcare products allowed for marketing and use, on the said date.
- Medical devices included in the ARTG prior to 25 November 2021. According to the guidance, with respect to such devices, transitional arrangements will apply in order to ensure continuous availability of the products on the market and prevent shortages in supply. In order to comply with the new requirements, the parties responsible for such devices should have notified the authority before 25 May 2022 about the products subject to reclassification, and submit the appropriate application for inclusion of a medical device in question in the register as a Class III medical device. The said application should be submitted before 1 November 2024. Should the party responsible for a medical device fail to complete these steps, it won’t be allowed to supply it from 1 November 2024.
- Application to include a medical device in the ARTG lodged before 25 November 2021. According to the guidance, in case the application for inclusion of an active implantable medical device in the register has been submitted before the date reclassification becomes effective, it will be reviewed by the authority and the device in question will be included in the register under an old classification. As in the previous case, a party responsible for a medical device will have to notify the authority about the product and then submit a new application for inclusion in the register under the new classification rules. Failure to comply with the said procedure will require the inclusion to be canceled.
- New application for inclusion submitted after 25 November 2021. As explained by the authority, all new applications should be submitted as applications for a Class III medical device.
Annual Reporting Requirements
The guidance also covers the aspects related to the reporting requirements set forth under the Regulations including, inter alia, annual reporting for the first 3 years from the date of inclusion in the register. In this respect, the authority mentions that for the products subject to reclassification, calculation of the said reporting period starts from the initial inclusion date. For example, a Class AIMD device that is already included in the ARTG for greater than three years and is transitioning to a Class III ARTG inclusion is excluded from 3 year annual reporting requirement. However, for devices that are at a lower classification (e.g., Class IIa) that are transitioning to Class III, and have not previously been subject to the 3 years of annual reporting, then these devices would be subject to the 3 years of annual reporting.
In summary, the present TGA guidance provides an overview of the new classification rules for active implantable medical devices. The document describes the way the transitional regime applies and also outlines the steps to be taken by the manufacturers in order to be allowed to continue supplying products covered by the scope of reclassification.
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