Regulatory Intelligence | September 2026

EU AI Act transparency obligations take effect, TGA opens a consultation on medical device information sharing, and Health Canada moves to continuous review of its recognised standards list.

Prepared by SciMed Consultancy Ltd for regulatory, legal, quality, and market-access teams operating under EU MDR, IVDR, UK MDR, and related global frameworks.

THIS MONTH IN BRIEF

• EU AI Act transparency obligations take effect: the AI Office begins enforcement from the 2nd of August.

  • Chatbots must disclose AI interaction; deepfakes and AI-generated content need machine-readable labelling

• TGA opens a consultation on sharing more information about medical devices, running from the 13th of August to the 2nd of October

• Health Canada opens a consultation on its List of Recognised Standards, moving to a continuous, year-round review process

INTRODUCTION

August was quieter than July on the page count, but not on substance. The AI Act's transparency obligations, the one part of the Omnibus timeline that was never delayed, arrived on schedule on the 2nd of August. Australia and Canada both opened consultations that manufacturers should treat as genuine opportunities to shape the rules, rather than routine paperwork to file away.

From the 2nd of August, chatbots must disclose that users are talking to AI, deepfakes must be labelled, and AI-generated content must carry a machine-readable mark. None of this is new in principle, it's the same Article 50 obligations flagged in last month's briefing, but it is now enforceable, with the AI Office and national authorities empowered to act on it.

Both the TGA's information-sharing proposal and Health Canada's recognised-standards consultation are still open. Neither imposes an immediate obligation, but both will shape how each regulator operates for years: the TGA's proposal touches what gets said publicly about a device under investigation, and Health Canada's shift to continuous review changes how manufacturers should engage with the standards list going forward.

RECENT DEVELOPMENTS | EU

EU AI Act Transparency Obligations Take Effect: AI Office Begins Enforcement

From the 2nd of August 2026, the European Commission's AI Office and national authorities began enforcing the AI Act, alongside the new transparency obligations under Article 50. This is the enforcement date this briefing has been tracking since the AI Act Omnibus confirmed it back in July: the postponed high-risk deadlines move to 2027 and 2028, but the transparency duties were never delayed, and they are now live.

Chatbots and other interactive AI systems must now tell users they're dealing with AI, not a human. Deepfakes, meaning images, video or audio edited or generated using AI, must be labelled, and AI-generated or altered content must carry a machine-readable mark so it can be detected. The Commission has published a first list of more than 180 organisations that have signed the Code of Practice on Transparency of AI-Generated Content, the framework that operationalises these obligations.

For MedTech and IVD manufacturers building AI into patient-facing tools, chatbots, symptom checkers, or any AI system that generates content a patient or clinician might see, this is the point to check disclosure and labelling are actually built into the product, not just documented as a future task. The high-risk deadlines bought time on the substance; they did not buy time on transparency.

»You can read the Commission's press release here.

RECENT DEVELOPMENTS | Australia

TGA Opens Consultation: Sharing More Information About Medical Devices

From the 13th of August 2026, the TGA opened a consultation on proposals to expand what it can lawfully release about a medical device following a post-market review or investigation. The consultation runs until the 2nd of October 2026.

The proposal would extend the TGA's ability to release information under section 61 of the Therapeutic Goods Act 1989, giving it more scope to communicate safety, quality and performance findings once a device has been the subject of regulatory review. It sits alongside the government's Action Plan for Medical Devices and aligns with the World Health Organisation's Global Benchmarking Framework on regulatory transparency.

Sponsors and manufacturers with devices on the Australian market should read the consultation paper closely; if adopted, it would materially change how much the TGA can say publicly about a device under investigation, before any final safety finding is reached.

»You can read the TGA's consultation paper here.

RECENT DEVELOPMENTS | Canada

Health Canada Opens Consultation: Moves to Continuous Review of Recognised Standards

Health Canada opened a consultation on the 27th of July on proposed changes to its List of Recognised Standards for medical devices, running until the 25th of September 2026. This falls just before our reporting window opened, but the consultation, and its implications, run through August.

The more significant change is procedural rather than substantive. Once this consultation closes, Health Canada will move from a periodic update cycle to a continuous, year-round feedback process: stakeholders can submit input on recognised standards at any time via the standards committee's mailbox, with submissions compiled and folded into an annual review rather than waiting for a formal consultation window.

Manufacturers relying on Canadian recognised-standards status for their technical files should use the current consultation to flag any gaps now, and should expect the annual review cycle, rather than occasional consultations, to become the primary way this list changes going forward.

»You can read the consultation notice from Health Canada here.

UPCOMING DEADLINES

The following confirmed deadlines fall will be upon us soon. Manufacturers, importers, and authorised representatives should verify their compliance status against each.

• 25th September 2026 | Health Canada

  • Consultation on the List of Recognised Standards for medical devices closes to new input.

• 2nd October 2026 | TGA

  • Consultation on sharing more information about medical devices closes.

• 27th November 2026 | EU

  • Legacy devices must be registered in the UDI/Device module of EUDAMED

• 2nd December 2026 | EU AI Act

  • Deadline for AI systems already on the market before the 2nd of August 2026 to complete machine-readable labelling of synthetic audio, image, video or text content under Article 50.

• 31st December 2026 | Swissmedic

  • Transition period for swissdamed registration ends for devices not subject to incident, FSCA or trend reporting.

• 2nd August 2027 | EU AI Act

  • Forward Planning

    National competent authorities must have established at least one AI regulatory sandbox.

• 2nd December 2027 | EU AI Act

  • Forward Planning

    Full high-risk obligations apply to standalone Annex III AI systems.

• 2nd August 2028 | EU AI Act

  • Forward Planning

    Full high-risk obligations apply to AI systems embedded in MDR/IVDR-regulated products.

Need help interpreting how these changes affect your organisation?

Regulatory changes rarely affect products in isolation. Classification strategy, evidence planning, market access, software change control, supply continuity, and lifecycle obligations increasingly overlap across jurisdictions.

If your team is assessing the operational or commercial implications of any of the developments above, we can help pressure-test the impact against your specific products, portfolio, or regulatory strategy.