Regulatory Intelligence | October 2026
IVDR transition milestones, revised evidence expectations, and device-specific AI proposals shape September’s regulatory agenda across major markets.
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
· IVDR Class C notified body agreement deadline passed on the 26th of September
· MDCG clarifies classification of standalone IVD quality controls
· UK Commission recommends staged authorisation and lifecycle oversight for AI-enabled devices
· FDA publishes PMA submission and surgical robotics drafts; radiology software exemption denied
· Canada changes exceptional-importation submissions and shipment notification timing
· TGA updates saline-only device classification and computational modelling guidance
· Japan consults on review points for generative AI medical devices
INTRODUCTION
September brought an important distinction between obligations manufacturers must already meet and proposals that may change future market access. The IVDR Class C agreement milestone passed, while revised EU classification guidance and Australian evidence guidance call for a fresh look at existing technical files. In the UK and Japan, the focus was on how AI-enabled medical devices should be evaluated and monitored throughout their working life.
For manufacturers, the immediate priorities are to confirm transitional eligibility, check whether revised guidance affects the evidence already held, and identify proposals worth commenting on. Across markets, intended purpose, documented risk controls and evidence of performance remain central to those decisions.
RECENT DEVELOPMENTS | EU
IVD Class C Transition: Notified Body Agreement Milestone Passed
On the 26th of September 2026, the written-agreement deadline fell for relevant Class C IVDs previously self-declared under the IVDD and relying on the IVDR transitional provisions. This was a scheduled milestone under the existing legislation, following the application deadline of the 26th of May 2026, rather than a new September rule.
Manufacturers should confirm that signed agreements cover the relevant devices and retain evidence that the other transitional conditions are met. A submitted application alone does not satisfy the agreement condition. Where a condition was missed, continued placement on the market cannot simply be assumed to remain lawful; the affected portfolio needs an immediate regulatory assessment.
» Read Commission’s IVDR transition Q&A.
MDCG 2020-16 Revision 5: IVD Quality-Control Classification Clarified
Published on the 9th of September, Revision 5 clarifies Rule 7 and updates its examples for controls without quantitative or qualitative assigned values. A manufacturer may indicate an analyte range for standalone quality-control material without that range becoming an assigned value, where the laboratory determines the target values it routinely uses. Unless another rule applies, these controls fall in Class B.
The distinction depends on intended purpose and the instructions for use. Standalone controls for monitoring laboratory examination procedures cannot replace mandatory controls verifying the IVD’s own performance. Manufacturers should review classification rationales and labelling; controls with manufacturer-assigned values, including assay-kit validity controls, follow implementing rule 1.6. This is interpretative guidance, not an amendment to the IVDR.
» Read revised MDCG classification guidance.
COMBINE Safety Reporting Guide: Responsibilities in Combined Studies
On the 11th of September, the Commission published the COMBINE Project 2 sponsors’ guide for studies combining medicinal products, medical devices and/or IVDs under the CTR, MDR and IVDR. The available document is version 01.01, dated the 21st of September. It brings together recording, assessment and reporting considerations, including national reporting routes for device investigations and IVD performance studies.
Sponsors should map safety processes across each applicable framework and document who assesses and reports each event. A common investigator recording form does not remove the separate responsibilities of multiple sponsors. National requirements still need checking, and ethics committee reporting is outside the guide’s scope. The practical task is to align protocols, safety agreements and reporting procedures before a combined study starts.
» Read COMBINE sponsors’ safety reporting guide.
Joint Scientific Consultations: September Request Window for Eligible Devices
On the 22nd of September, HaDEA announced a joint scientific consultation request window running from the 23rd of September until the 21st of October for eligible technologies, including Class IIb and III devices and Class D IVDs likely to undergo joint clinical assessment. The opportunity concerns clinical-study planning for HTA; it does not replace conformity assessment.
Applying developers should align their evidence plans and consultation preparation; others should monitor subsequent calls before fixing pivotal study designs. The relevance is the opportunity to address HTA evidence needs early, alongside the evidence required for regulatory market access.
RECENT DEVELOPMENTS | UK
Health Bill Amendments: Enabling Powers for a Future Device Licensing Regime
On the 1st of September, the MHRA announced proposed Health Bill amendments covering information sharing, the updating of legislation and powers to develop a future medical device licensing regime. The domestic route being explored could involve MHRA-issued licences, with scrutiny proportionate to product risk, including for software and AI medical devices.
The announcement did not establish a new licensing route or remove existing requirements. Detailed design would require further policy work, consultation and parliamentary scrutiny; the MHRA stated that UKCA arrangements remained in place while a future model was developed. Manufacturers should track the proposals when planning GB market access, while continuing to work to the applicable routes and distinguishing Great Britain from Northern Ireland.
» Read MHRA’s Health Bill announcement.
AI in Healthcare Commission: Staged Authorisation and Lifecycle Monitoring Recommended
On the 10th of September, the independent National Commission into the Regulation of AI in Healthcare published recommendations for a future framework. For AI-enabled medical devices, the proposals include supervised staged authorisation, continuous real-world monitoring, stronger traceability and clearer allocation of responsibility for risk controls between manufacturers and healthcare providers.
At September’s close these were recommendations, not newly binding device requirements. Developers should nevertheless assess whether their evidence plans, software version controls and deployment arrangements can support ongoing performance evaluation. Particular attention belongs on the operating conditions needed for safe use and who delivers each control.
RECENT DEVELOPMENTS | USA
PMA Electronic Submission Template: FDA Publishes Draft Guidance
The FDA posted draft guidance on electronic templates for premarket approval applications and certain PMA supplements on the 17th of September, followed by the Federal Register notice on the 18th. The draft introduces the resources supporting structured electronic submissions and describes the intended direction for submission standards, implementation timing and exemptions when finalised.
This is a draft, not a new immediate requirement to submit every PMA through eSTAR. Teams preparing PMAs should compare their document structure with the proposed template and identify any practical issues before the comment date of the 17th of November 2026. Submission plans should continue to follow the currently applicable requirements and the scope of the relevant application type.
» Read FDA’s PMA template draft guidance.
Radiology CAD and Triage Software: Partial 510(k) Exemption Denied
A final order published and effective on the 17th of September records FDA’s denial of a petition seeking a partial 510(k) exemption for four radiology computer-aided detection, diagnosis and triage device types. The petition concerned specified conditions for manufacturers already holding relevant clearances. FDA had communicated the denial to the petitioner on the 1st of April; September’s order formally published that determination.
Despite the order’s title referring to an exemption, it does not grant one. Developers of affected imaging software, including AI-enabled products, should retain the applicable premarket notification strategy. A previous clearance and a post-market monitoring plan do not, through this petition, create an exemption for a further product.
» Read FDA’s published final order.
Robotically-Assisted Surgical Devices: Draft Premarket Evidence Recommendations
On the 24th of September, the FDA posted draft guidance addressing premarket submissions for certain robotically-assisted surgical devices; the Federal Register notice followed on the 25th of September. It addresses device descriptions, non-clinical testing, in vivoevaluation and labelling. Comments are requested by the 24th of November 2026.
Developers should map the draft against their verification, validation and evidence programmes, including software and any AI-enabled functions. Scope matters: the draft does not cover remotely teleoperated devices or autonomous robots performing significant parts of operative procedures independently of qualified practitioners. It should not be read as an authorisation pathway for autonomous surgery. The recommendations remain draft and non-binding.
RECENT DEVELOPMENTS | Canada
Exceptionsal Importation Submissions: New Attestations and Shorter Notification Lead Time
On the 2nd of September, Health Canada updated forms FRM-0577 and FRM-0578 for exceptional importation and sale of foreign-authorised medical devices. Beyond conversion to web forms, both now include attestations concerning applicable distribution records, complaints, incident reporting, serious-risk information and recall procedures. Proposals also request shortage/substitution evidence and supporting foreign authorisation and QMS documentation.
For shipments under this route, notification is now required three business days before arrival, (as opposed to the five required previously), with lot and expiry information added. Importers should update submission checklists and confirm that the procedures behind the attestations are documented. These are operational changes to the exceptional-importation route, not a general relaxation of Canadian device licensing.
RECENT DEVELOPMENTS | Australia
Saline-Only Flushing Devices: Class IIa Classification Rule Applies
The TGA announced a new classification rule applying to ARTG applications from the 7th of September. Non-invasive devices containing only saline and intended to maintain the patency of, or flush the lumen of, another medical device fall in Class IIa under Clause 2.2. Examples include pre-filled saline flush syringes and vascular access device locking solutions.
Existing ARTG entries and applications lodged before the 7th of September have a five-year transition from that date. Sponsors should check composition, intended purpose and application timing before assigning the route. Devices containing a medicine remain subject to Clause 5.1; the saline-only provision should not be generalised to every combination product.
» Read TGA’s classification announcement.
Computational Modelling & Simulation: TGA Updates Evidence Guidance
On the 11th of September, the TGA updated its clinical evidence guidelines to add computational modelling and simulation, alongside updated guidance on demonstrating compliance with the Essential Principles. The latter explains how modelling can support scientific and engineering questions within an overall evidence package, with verification, validation and uncertainty analysis proportionate to its use.
Manufacturers using in silico methods should document model credibility, link outputs to meaningful outcomes and explain how they complement any clinical evidence needed. Modelling should not be presented as clinical evidence in itself or treated as a blanket replacement for required clinical data. This is particularly relevant when simulation supports software, implant or other device performance claims.
» Read TGA’s updated Essential Principles evidence guidance and the updated clinical evidence guidelines.
RECENT DEVELOPMENTS | Switzerland
IVD Materiovigilance: Swissmedic Publishes Good Practice Guidance
On the 10th of September, Swissmedic published GPMV-IVD, its good practice guidance for vigilance in in vitro diagnostics. It is aimed at professionals using IVDs in laboratories and hospitals, including point-of-care testing, and those responsible for vigilance. It addresses serious-incident reporting, field safety corrective actions and the responsibilities of the vigilance function.
For IVD manufacturers and suppliers, the practical implication is to check how customer incident reports reach their own complaint and vigilance systems, and how field actions are communicated to laboratories. The guidance’s primary audience is users; it should not be described as imposing a new manufacturer reporting deadline. Swiss supply and support arrangements should accommodate the user reporting processes it explains.
RECENT DEVELOPMENTS | Japan
Generative AI Medical Devices: PMDA Opens Draft Review-Points Consultation
On the 18th of September, PMDA opened consultation on draft review points for medical devices using generative AI. The document itself is dated the 14th of September; the regulator’s consultation listing establishes the public release date. Comments are invited until March next year. The draft considers evaluation and post-market issues specific to generative AI medical devices, rather than general-purpose AI regulation.
Developers considering Japan should review how their intended-use boundaries, performance evaluations and user controls address variable outputs, hallucination and human interpretation. The document also addresses post-market responses and human factors. These remain draft review points, not a final new approval standard, but provide an opportunity to identify evidence gaps and comment on how generative AI devices can be assessed in practice.
UPCOMING DEADLINES
The following confirmed dates fall within 90 days of preparation. Consultation dates are opportunities to comment; registration dates are compliance milestones. Check applicability to each device and market.
2nd October 2026 | TGA
Consultation on sharing more information about medical devices closes.
17th November 2026 | FDA
Submit comments on the robotically-assisted surgical devices premarket submissions draft (FDA-2026-N-9505).
24th November 2026 | FDA
Submit comments on the robotically-assisted surgical devices premarket submissions draft (FDA-2026-N-9505).
28th 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.
