The new article clarifies the particular conformity assessment procedure to be applied in the context of medical device systems and procedure packs. 

TGA Guidance on Clinical Evidence for Implantable Pulse Generator Systems: Overview

The Therapeutic Good Administration (TGA), an Australian regulating authority in healthcare products, has published a guidance document dedicated to the medical device systems and procedures packs intended to be marketed and used in the country.
The document provides an overview of the applicable regulatory requirements and additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance with them.

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they 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 amendments to the underlying legislation.

Introduction to Special Conformity Assessment Procedure

The scope of the guidance covers, among other things, the aspects related to the special conformity assessment procedure that allows SOPP manufacturers to declare compliance with specific regulatory requirements once they meet the eligibility criteria set out in Regulation 3.10.

This declaration pertains to clause 7.5 of Schedule 3 of the Regulations and covers detailed information about the items within the SOPP, associated documentation, and the manufacturing process.

Key aspects include identification of each item, provision of usage instructions, evidence of conformity assessments, and verification of mutual compatibility among the items.

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Mutual Compatibility and Its Importance

As explained by the authority, mutual compatibility is a critical component that SOPP manufacturers must demonstrate through documentary evidence.
This evidence should confirm that the components within the SOPP work together as intended, without any conflicts or adverse reactions.

Compatibility entails the seamless performance of combined devices, including software, without needing modifications, ensuring their collective use does not lead to conflicts or interference.

Recent Refinements to Conformity Assessment Requirements

Following changes effective 25 November 2021, the particular conformity assessment procedure now includes additional declaration requirements for SOPP manufacturers.

These include possessing a conformity assessment document for each medical device, declarations of conformity for Class I and Class 1 IVD devices, statements for custom-made devices, and evidence of quality assurance procedures for sterilization.

Moreover, manufacturers must demonstrate that modifications to component devices or packaging comply with quality, safety, and performance standards.

Custom-Made Medical Devices: New Definitions and Regulations

The definition of custom-made medical devices was revised on 25 February 2021, impacting how these devices are regulated within SOPPs.
These devices, now defined under Regulation 1.3, are exempt from ARTG inclusion but must be accompanied by a written statement from the manufacturer, prepared by sub clause 7.2(2) of Schedule 3.

The authority also provides guidance for information to be provided by manufacturers of custom-made medical devices.

Record Retention Requirements for Manufacturers and Sponsors

Manufacturers must retain manufacturing records depending on whether the SOPP includes implantable medical devices – 5 years for non-implantable and 15 years for implantable.

These records must be available upon request by the TGA. Sponsors also have defined retention periods for their records, are required to support the distribution of SOPPs, and must comply with TGA requests for documentation.

Additional Requirements under the Special Conformity Assessment Procedure

The regulations stipulate specific information that must accompany any medical device, including those within SOPPs.
The information must cover manufacturer details on labels, instructions for use, and patient implant cards, ensuring transparency and compliance with essential principles (EPs) defined in the regulatory framework.


The particular conformity assessment procedure described in the present guidance constitutes a comprehensive framework for SOPP manufacturers, ensuring the safety, compatibility, and efficacy of medical devices within these systems.
This framework not only supports the innovative integration of medical devices but also ensures the continued safety of patients and proper product quality.

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