The present guidance provides additional details regarding the regulatory requirements for active and passive implantable medical devices.
The Therapeutic Goods Administration (TGA), an Australian regulatory agency in the sphere of medical devices, has published a guidance document dedicated to the regulatory requirements for clinical evidence to be provided by responsible parties to substantiate the applications for medical device marketing approval. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should it be reasonably necessary to reflect the corresponding amendments to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the use of medical devices in the Magnetic Resonance (MR) environment. In this respect, the authority mentions that in terms of safety, the following categories are to be applied: “MR safe”, “MR conditional”, and “MR unsafe”. Based on the mode of action, the document also distinguishes between Active Implantable Medical Devices (AIMD), and Passive Implantable Medical Devices (PIMD).
Requirements for PIMDs
According to the guidance, the experimental data collected by the virtue of the application of non-clinical testing methods will be required in case of PIMDs that are considered to be “MR conditional”. In this respect, the authority outlines the scope of standards describing the methods to be applied. The authority additionally emphasizes that in case the scope of testing does not cover any sizes or combinations of the device in question, it should anyway include the combination representing the worst-case scenario. As further explained by the authority, the mandatory elements of the testing protocol should contain the following:
- Test objective;
- Equipment used;
- Acceptance criteria;
- The rationale for test conditions;
- The rationale for the acceptance criteria;
- Number of devices tested;
- Description of devices tested, including device size;
- Description of any differences between the test sample and the final product, and justification for why differences would not impact the applicability of the test to the final product;
- Results (summarized and raw form).
For the regulatory status of the product in other jurisdiction, the authority mention that in case the same or similar product is already allowed for marketing and used in another jurisdiction, a party responsible for the product should provide the appropriate details to the authority (i.e., the number and date of the certificate issued, together with the name used to market the device, as well as the wording of the intended purpose and MR status).
The scope of the guidance also covers the aspects related to post-market data collected in the course of using the device in Australia or abroad. In particular, the authority states that the information to be provided in this respect should include, inter alia, the following details:
- Any recalls or withdrawals conducted for the device, or changes to the instructions for use;
- Information about the number of devices distributed (per country);
- The number of years the device in question is in use;
- The key data from post-market vigilance reports to adverse events and reportable issues;
- Post-market data collected in other countries the device is marketed in;
- The explanation for the returns related to failures or malfunctions of devices, together with the details of corrective measures associated thereto.
AIMD: Key Points
The document also highlights the key points related to active implantable medical devices and the regulatory requirements they are subject to. According to the guidance, an active medical device is a device that uses and converts energy in a significant way to operate. Following the applicable legislation, namely, the Therapeutic Goods (Medical Devices) Regulations 2002, all AIMDs could be divided into the following categories:
- Active medical devices for diagnosis, that are intended by the manufacturer to be used … for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities; and
- Active medical devices for therapy that are intended by the manufacturer to be used … to support, modify, replace or restore biological functions or structures to treat or alleviate an illness, injury, or handicap.
The authority also mentions that some of the devices could be used for both therapeutic and diagnostics purposes simultaneously. This applies, inter alia, to cardiac devices composed of such elements as circuity, battery, case, pacing lead(s), and connector block. According to the guidance, such devices include:
- Permanent pacemakers (PPM) – the devices intended to regulate abnormal heart rhythm;
- Implantable cardioverter defibrillators (ICD) are intended to generate low-energy or high-energy impulses depending on the current needs;
- Cardiac resynchronization therapy (CRT) devices are used to address the lack of synchrony between the left and right ventricles.
The authority explains that irrespective of the AIMD type, the scope of information to be submitted by the applicant should include, inter alia, the details about:
- The materials used, and chemical composition;
- Components of the product in terms of dimensions;
- Other devices that could be potentially used together with the device in question.
In summary, the present guidance describes the regulatory approach to be applied concerning active and passive implantable medical devices. The document outlines the key point associated with each type of implantable medical device, provides the appropriate definitions, and also highlights the main aspects to be taken into consideration by medical device manufacturers when determining the regulatory status of the product they are responsible for, and also the scope of the information they authority would expect them to submit when applying for marketing approval.
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