The article provides an overview of the new classification rules to be applied.
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a set of guidance documents dedicated to the recent changes to classification rules for medical devices. The scope of the changes implement covers, inter alia, Active Implantable Medical Devices (AIMD). The aspects related to the new classification rules for general AIMD products are addressed in a separate guidance document issued by the TGA, while the present guidance is dedicated to the reclassification of active implantable medical devices for therapy with a diagnostic function. The document provides an overview of the transitional arrangements and corresponding obligations the parties involved should fulfill in order to be allowed to continue supplying their products in Australia. In particular, the guidance provides additional clarifications regarding the new classification rules, as well as recommendations to be taken into consideration in order to ensure compliance thereto. At the same time, the document itself is not intended to introduce new rules or impose new obligations, and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
First of all, the authority states that from 25 November 2021 active medical devices for therapy with a diagnostic function will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices. The initial public consultations related to the proposed changes to the classification rules have been carried out by the authority earlier in 2019. The changes suggested were broadly supported by the industry. According to the new rules, AIMDs for therapy with the diagnostic function shall be reclassified from Class IIa (low-medium risk)/Class IIb (medium-high risk) to Class III (high risk).
The reclassification described herein would result in corresponding changes to the requirements the products covered by its scope are subject to, namely:
- The Quality Management System (QMS) implemented by the medical device manufacturer would be subject to a more rigorous assessment, the same will apply to the technical documentation accompanying the device;
- Procedures reflected in conformity assessment documents should be appropriate for a Class III device;
- The applications for inclusion in the Australian Register of Therapeutic Goods (ARTG), a country’s register of healthcare products allowed for marketing and use, would be subject to a mandatory audit, including a rigorous assessment of clinical evidence provided to substantiate the claims.
AIMD in Question
The document further provides additional details regarding the products subject to reclassification. According to the definition provided in the Therapeutic Goods (Medical Devices) Regulations 2002, an active medical device for therapy means an active medical device that is intended by the manufacturer to be used on a human being, either alone or in combination with another medical device, to support, modify, replace or restore biological functions or structures for the purpose of treating or alleviating an illness, injury or handicap. As it was mentioned before, starting from 25 November 2021, such products are classified as Class III medical devices and, consequently, are subject to any and all regulatory requirements for the said class of medical devices.
According to the guidance, the scope of medical devices falling within the scope of reclassification includes, inter alia, the ones where a diagnostic function has a significant impact on patient management – for instance, fully or semi-automated external defibrillators. The products subject to reclassification could be used to examine or monitor the patient’s condition, and also to determine the patient management based on the diagnostic results (e.g., make changes to the therapy the patient is subject to). Examples of such devices include, inter alia, the following ones:
- Automated external defibrillators,
- Closed loop systems,
- External pacemakers,
- Intravascular heating/cooling system control units,
- Hyperthermia systems,
- Temperature mapping units,
- Intraperitoneal-circulation hypothermia system control units,
- Mechanical bloodstream indicator injectors.
The guidance also provides an example of an automated external defibrillator that can assess a patient’s heartbeat and initiate active therapy, should threatening fibrillation be detected.
At the same time, the authority additionally emphasizes that continuous positive airway pressure devices will not be subject to reclassification since they are considered to be medium-risk devices that are not supposed to determine significantly patient management. The automatic pressure adjustment such products can offer is intended to ensure the comfort of patients, and is not related to diagnostic function, hence, they are falling outside the scope of the new approach to AIMD classification.
It is also stated that reclassification covers programmed and programmable medical devices, as well as any and all software-based medical devices. The TGA encourages medical device manufacturers to review the classification rules the device in question could be subject to, and also mentions that in case a few of the apply, the highest classification should be followed.
Actions to be Taken
The guidance also outlines the scope of actions to be taken by the parties responsible for medical devices subject to reclassification in order to be allowed to continue supply after the transition period expires. The particular steps will depend on the regulatory status of the product or the application for inclusion associated thereto on 25 November 2021. Under the general rule, medical device manufacturers would have to notify the authority about the products subject to reclassification they are responsible for, and then apply for the inclusion of such products in the ARTG under the new classification rules.
In summary, the present TGA guidance provides an overview of the new classification rules for active implantable medical devices with diagnostic functions. The document outlines the scope of medical devices subject to reclassification, explains the grounds for it, and also describes the steps to be taken in order to ensure the uninterrupted availability of these products on the market.
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