TGA Publishes Digital Scribe Review Outcomes (October 2026): A Blanket “Not a Medical Device” Statement Does Not Settle the Question

Published: 3 November 2026  |  Category: Classification and technical guidance

On 16 October 2026 the Australian Therapeutic Goods Administration (TGA) published the outcomes of its targeted review of digital scribes supplied in Australia and updated its accompanying Digital scribes guidance. The review found that not one of the suppliers reviewed had classified its product as a medical device, while many products already contain functions that very likely meet the statutory definition of a medical device. The TGA made clear that a general disclaimer is not sufficient to determine status: the assessment turns on intended purpose, as established by labels, instructions for use, advertising, websites and technical documentation taken together.

Review outcomes published on 16 October

On 16 October 2026, the Australian Therapeutic Goods Administration (TGA) published the outcomes of its targeted review of digital scribes supplied in Australia and simultaneously updated its Digital scribes guidance. The review set out to answer three questions: which of these products are actually on the Australian market; which of their functions may already meet the statutory definition of a medical device; and how well suppliers understand their own obligations.

In its news release of the same day, the TGA stated that the conclusions will be used for three purposes: adjusting its regulatory approach, continuing education and guidance, and taking targeted compliance action where necessary.

No supplier acknowledged that it was making a medical device

The numbers are not the point. What makes this review notable is a contrast. The TGA wrote that none of the suppliers reviewed had classified its product as a medical device, yet the review found that many products already contain functions that very likely meet the definition of a medical device.

The page also identifies a more difficult problem: some suppliers may not previously have considered medical device compliance requirements at all. These products are already embedded in clinical workflows and widely used across a range of clinical departments — clinicians use them every day, while suppliers maintain them as office software.

A disclaimer does not prevent classification

Many products state on their interface or promotional pages that “this product is not a medical device” or “not intended for diagnosis”. The TGA's position is direct: such statements or disclaimers are not sufficient to determine whether a product is a medical device. The assessment turns on intended purpose, and intended purpose is established by several sources together: labels, instructions for use, advertising and promotional material, product websites and other marketing material, technical documentation describing how the product works or is intended to be used, and the way the product is presented to users.

The TGA gave a concrete example: a tool that only summarises a consultation will still be treated as a medical device if the manufacturer claims it is used to support the diagnosis, prognosis or treatment of a disease or injury.

Conversely, where a product does make medical claims, or has functions consistent with a medical device, a general disclaimer cannot pull it back. The correct approach is first to reduce the risk of reasonably foreseeable misuse through design or other protective measures, and only then to consider warnings.

The seven-function comparison table

The updated guidance contains a seven-row comparison table that splits the same category of function into a “not a medical device” column and a “medical device” column:

• Viewing medical history: presenting or organising the complete information in the record does not count; identifying, selectively displaying, ranking or analysing information to generate diagnostic or treatment recommendations does.
• Drafting referral letters: aggregating only information the doctor has already stated or recorded does not count; adding information in order to generate diagnostic or treatment recommendations does.
• Summarising records: organising or summarising without judging clinical significance does not count; filtering, ranking, analysing or interpreting in order to generate recommendations does.
• Medical coding: merely mapping already-recorded clinical information into codes does not count; generating diagnostic conclusions or recommendations based on coded output does.
• Reference material: retrieving or displaying does not count; applying reference information to a specific patient and interpreting it into recommendations does.
• Chat function: helping users search, filter, navigate and manage information does not count; generating new clinically relevant conclusions or recommendations that the doctor did not raise does.
• Insight function: organising, summarising and communicating existing information does not count; generating new conclusions such as diagnoses, prognoses, test or treatment plans, or follow-up recommendations does.

Eight examples: five are not devices, three are

The guidance includes eight examples. The first five illustrate when a product is not a medical device:

• Converting consultation dialogue into text only.
• Summarising only, with the doctor editing the output before it is saved to the electronic medical record.
• Organising information into a structured record that the doctor confirms.
• Matching codes only against terms explicitly mentioned in the conversation.
• Drafting discharge summaries or letters to a template without judging which content in the record is relevant.

The last three are medical devices:

• Adding “insights” to a summary that give diagnostic, follow-up or treatment recommendations.
• A function that is administrative summarisation only, but which is marketed as supporting and guiding diagnostic and treatment decisions and improving patient outcomes.
• A digital agent that finalises and files records without physician review, and that can decide for itself which tests are needed and order them directly.

The third example deserves separate attention. The line it crosses is “acting in place of the doctor”; “giving advice” remains on this side of that line.

Once classified, only a few routes remain

Where a product is confirmed to have a therapeutic purpose and to be a medical device, but does not replace clinical judgement and only provides recommendations to healthcare professionals, it may fall within the clinical decision support system (CDSS) exemption. The conditions are not generous:

• The sole purpose must be to provide recommendations to healthcare professionals regarding the prevention, diagnosis or treatment of disease;
• It must not replace clinical judgement;
• It must not analyse information derived from another medical device;
• It must display how the recommendation was generated.

Even where the exemption applies and inclusion in the Australian Register of Therapeutic Goods (ARTG) is not required, the product remains a regulated medical device: it must satisfy the Essential Principles of safety and performance, and the supplier must notify the TGA using the CDSS exemption notification form.

Where the exemption is not available, or not all conditions can be met, only three routes remain: stop supplying the product; remove the functions that have a therapeutic purpose; or apply for ARTG inclusion. Supplying a product that is neither exempt nor included in the ARTG is an offence under the Therapeutic Goods Act 1989.

From 1 November, the exemption provisions themselves were redrafted

In parallel with the review, the TGA announced on 8 September 2026 that amendments to the clinical decision support system exemption take effect on 1 November 2026, made through the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026.

The TGA's position is that the amendments do not change the scope of the exemption and do not introduce new regulatory requirements; their purpose is to state more clearly when the exemption applies. At the same time, the CDSS guidance page was still marked on 16 October 2026 as “under review to align with the amendments commencing 1 November 2026”. For companies, this means a period of overlap in the assessment basis: the provisions are already in force while the interpretive guidance is still being updated.

Enforcement approach: education first, then targeted action

The TGA did not present this review as a sweep. It stated that it will apply “proportional compliance” under its compliance framework, continue to provide guidance and education, and undertake targeted compliance activities where necessary. The weight of that sentence lies in the sequence: inform first, enforce second.

It also confirms that enforcement is real. Where the functions identified in the review continue to be supplied, the risk sits with the supplier, not with the hospital.

Sources and scope of verification

Sources:

• Therapeutic Goods Administration (TGA), Digital scribe review outcomes, published 16 October 2026 — https://www.tga.gov.au/resources/publication/corporate-reports/digital-scribe-review-outcomes
• TGA, Digital scribes guidance, last updated 16 October 2026 — https://www.tga.gov.au/products/medical-devices/software-and-artificial-intelligence-ai/overview/types-software-based-medical-devices/digital-scribes
• TGA news, Outcome of digital scribe review, 16 October 2026 — https://www.tga.gov.au/news/news-articles/outcome-digital-scribe-review
• TGA news, Clinical decision support system exemption amendments, 8 September 2026 — https://www.tga.gov.au/news/news-articles/clinical-decision-support-system-exemption-amendments
• Federal Register of Legislation (Australia), Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026, 8 September 2026 — https://www.legislation.gov.au/F2026L01167/latest/text

Scope of verification and access date: the four TGA pages listed above were verified for this article, with particular attention to the publication date of the review and its three stated purposes, the position on suppliers' self-classification, the statement that disclaimers are insufficient to determine status, the seven-function comparison table, the classification of the eight examples, the four conditions and notification requirement of the CDSS exemption, and the announcement that the exemption amendments commence on 1 November 2026. Access date: 3 November 2026. The number of products and the list of manufacturers covered by the review could not be obtained from the publicly readable pages; this article therefore cites no specific figures and makes no determination regarding any specific product.

Applicability note: this article is an interpretation of publicly available regulatory information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. Whether a product is a medical device must be determined against the original TGA texts and the specific intended purpose, with the official texts prevailing; information may change with subsequent official updates.

AIMEILI regulatory interpretation

Intended purpose is built from the whole record, not from one sentence

The TGA position reflects the approach now applied across major jurisdictions: classification follows intended purpose as presented to the user and to the market, and a negative statement cannot neutralise positive claims made elsewhere. For suppliers, the practical consequence is that the website, sales deck, app store listing, onboarding screens, instructions for use and technical file are read together as a single statement of intended purpose. Any single element that promises diagnostic, treatment or decision-support benefit can convert a documentation product into a regulated device.

Assessment is moving to the level of individual functions

The seven-function table is the most operationally useful element of the package. It shows that the TGA assesses functions rather than whole products, and that the same nominal feature can sit on either side of the line depending on what the output actually does. A product may therefore be partly in scope and partly out of scope. Feature-level triage, with clear documentation of why each function is considered non-device, is now the defensible approach; a single product-level classification statement is not.

The CDSS exemption remains narrow and cumulative

The four conditions apply together, and two are frequently underestimated in practice. The requirement that the software must not analyse information derived from another medical device is directly relevant to integration with monitors, infusion pumps, laboratory systems and imaging sources. The requirement to display how the recommendation was generated demands explainability built into the interface, not merely described in documentation. Notification to the TGA through the exemption form is a separate and independent obligation; exemption from ARTG inclusion is not exemption from regulation, and the Essential Principles continue to apply in full.

A period of overlap between the law and the guidance

The amended exemption provisions took effect on 1 November 2026, while the supporting guidance was still marked as under review as of 16 October 2026. During such a period, the conservative reading of the text is the safer basis for a conformity decision, and any assessment should be documented with the version of the guidance relied upon and dated, so that it can be revisited once the final guidance is published.

Enforcement sequence signals priorities, not immunity

“Proportional compliance” with education first indicates that the TGA intends to give industry a reasonable opportunity to correct position. It does not create a grace period. Where a supplier is notified and continues to supply unchanged, the proportionality assessment shifts, and the exposure is the supplier's rather than the customer's.

Business impact

1. Marketing and claims need an immediate audit

Australian-facing websites, product brochures, demonstration videos, conference material, app store descriptions and sales scripts should be reviewed against the technical file and instructions for use. Claims such as “improves diagnostic accuracy”, “guides treatment decisions”, “reduces missed diagnoses” or “supports clinical decision-making” should be either substantiated and treated as device claims, or removed. Divergent claims across markets create additional risk, because regulators routinely read a company's global website.

2. Product roadmaps require feature-level decision points

Each function in the roadmap should be assessed against the TGA table before release, with a documented decision: keep the function outside the device boundary by design (for example, presenting information without generating clinical conclusions), remove it, or bring it into scope and regulate it. Adding summarisation-based recommendations, ordering capability or autonomous finalisation is not an incremental feature update; it changes regulatory status.

3. Regulatory pathway and evidence must be decided early

Where a function is in scope, the choice between the CDSS exemption route and ARTG inclusion determines the evidence package, quality management system expectations and post-market obligations. The exemption route requires the notification form, documented fulfilment of all four conditions, and a defensible display of how recommendations are generated. The ARTG route requires a conformity assessment pathway and Australian sponsor arrangements.

4. Commercial and contracting exposure

Hospitals, health services and procurement bodies are becoming more explicit in asking suppliers to confirm device status, and distributors may seek warranties and indemnities on regulatory classification. Suppliers should prepare a clear, documented classification position per product and per function, and align contract language with it. A position that cannot be supported by documentation is difficult to defend in a procurement dispute or a regulatory enquiry.

5. Recommended immediate actions

• Inventory every function supplied into Australia and map each against the seven-function table.
• Reconcile intended purpose across labels, instructions for use, websites, marketing and technical documentation; correct inconsistencies.
• Where a device is identified, either submit the CDSS exemption notification (confirming all four conditions) or remove the therapeutic function, or cease supply pending ARTG inclusion.
• Record the regulatory basis, the guidance version and the date of the assessment, and schedule a review once the TGA publishes the updated CDSS guidance.
• Check consistency with EU MDR and US FDA positions on clinical decision support and documentation software, so that a single global claims set can be defended in all markets.

Editorial note: this article is an interpretation of public regulatory information for professional reference only and does not constitute a regulatory determination, legal advice or a commitment regarding any specific product, company or application. Whether a product is a medical device must be assessed against the original TGA publications and the specific intended purpose.