Global Regulatory Intelligence Review

EUDAMED registration deadline is 28 November

EU · MD + IVD · Upcoming · Action required

EUDAMED's first four modules became mandatory on 28 May 2026. Manufacturers whose MDR/IVDR or legacy devices were already on the EU market, and which continue to be placed on the market, must register them in the UDI/Device module by 28 November 2026 (Commission timeline; Regulation (EU) 2024/1860). The duty sits in MDR Art. 123(3)(e) and IVDR Art. 113(3)(fa).

Under the MDR, a device must also be registered whenever a PSUR, serious incident, FSCA or trend report is submitted through EUDAMED. Devices placed on the market for the first time after 28 May 2026 already need registration before placing.

Japan sets expectations for companion diagnostics in oncology

Japan · IVD (+ SaMD CDx) · New · Review

PMDA's "Points to Consider for the Development of Companion Diagnostics Developed in Parallel with Anti-cancer Drugs (Early Consideration)", dated 5 October and posted 19 October, sets out when a CDx is needed — for patient selection, dose optimisation or treatment discontinuation (PMDA What's New; PMDA document). The assay used in pivotal trials should be the one submitted as the CDx; if the marketed assay will differ, developers should show analytical equivalence through a concordance study.

A CDx or partial-change application may be needed even where an approved assay already measures the biomarker but lacks a CDx intended use for the drug. PMDA asks developers to consult as early as possible and no later than the consultation on pivotal-trial design, and expects the CDx to be covered by insurance by the drug's NHI price listing. The document is non-binding guidance, not a new legal requirement.

Australia finds most AI digital scribes likely to be devices

Australia · SaMD/AI · Clarification · Review

TGA reviewed 12 digital scribes, none of which their suppliers had identified as medical devices (TGA). Eight included functions likely to meet the device definition, two needed more information and two appeared unlikely to be devices.

The functions that tip a scribe into regulation are generative-AI features that go beyond transcription and summarisation, such as analysing information, deciding what is clinically relevant or generating conclusions and recommendations. TGA notes that disclaimers do not determine regulatory status and says it will take a proportionate, risk-based approach to compliance. Suppliers of AI documentation tools in Australia should revisit their qualification assessment against intended purpose.

Taiwan moves device labels and IFU fully online

Taiwan · MD + IVD · Revised · Review

From 1 October 2026, TFDA is trialling "online review, originals kept on file" for Class I–III registration, change and extension applications: documents are uploaded as colour-scanned PDFs and firms keep the paper originals (TFDA announcement). TFDA no longer issues paper approved copies of labels, IFU or packaging for Class II and III approvals; electronically sealed versions in the TFDA Medical Device License System replace them.

Fees for e-submissions are paid through the system. Taiwan licence holders should make the electronic approved version their controlled labeling reference.

MHRA publishes 2026/27 registration fees

UK · MD + IVD · Revised · Informational

MHRA's registration guidance was updated on 16 October with the 2026/27 annual fee of £300 per Level 2 GMDN category, or per Level 1 category where no Level 2 exists (GOV.UK). No new MDCG documents or Commission guidance revisions were published in the window; the latest remains MDCG 2020-16 rev.5 of September 2026.

IMDRF consults on labeling principles

IMDRF · MD + IVD · Proposed · Review

IMDRF's Good Regulatory Review Practices working group has opened consultation on Edition 3 of N52, Principles of Labeling for Medical Devices, from 5 October to 3 December 2026 (IMDRF). Manufacturers with labeling and e-IFU programmes across IMDRF markets may want to comment.

Japan's generative-AI device review points

Japan · SaMD/AI · Proposed · Review

PMDA posted the English translation of its draft "Review Points for Medical Devices Utilizing Generative AI" on 14 October (PMDA What's New; PMDA SaMD page). Comments run from 18 September 2026 to 17 March 2027 (PMDA comment page). The draft is not final review criteria.

Korea proposes Class II one-stop review and AI advertising ban

South Korea · MD · Proposed · Review

MFDS Notice 2026-445 proposes amendments to the Medical Devices Act Enforcement Rule, with comments open from 14 September to 26 October 2026 (now closed) (Korea legislative notice). Proposals include paid advance review of whether a product is a device and of its class, a one-stop linked certification and technical-document review for Class II devices, procedures for emergency-introduction devices and a ban on advertising that uses AI-generated content to imply expert recommendation.

Other proposals widen clinical trials at non-designated institutions, waive fees for accessibility-feature devices and expand permitted purchase sources. Korea regulates IVDs under a separate act, so these provisions should not be assumed to apply to IVDs.

EU MDR/IVDR revision and other drafts

EU / China · MD + IVD · Proposed · Review

The Legislative Observatory lists an indicative first-reading plenary date of 14 December 2026 for the MDR/IVDR targeted revision, and the Legislative Train shows the file as tabled (OEIL; Legislative Train). Indicative dates are forecasts, and current requirements are unchanged. In China, CMDE's draft revision of the service-life registration review guidance for active devices closed for comment on 9 October (CMDE sub-centre).