Our MedTech news for October 2026 covers notified body positions on the MDR and IVDR revision, the UK’s confirmation that CE-marked devices will be recognised indefinitely, and the UK Government’s acceptance of all 44 recommendations on regulating AI in healthcare.
In the EU, Team-NB also updated its IVDR certification process consensus document, whilst in the US, the FDA released draft guidance on robotically assisted surgical devices, CDRH published its FY 2027 guidance priorities, and the FDA replaced “animal” with “nonclinical” testing terminology.
In Asia Pacific, China’s NMPA consulted on simplified cross-provincial registration and GMP inspection guidelines for standalone software and AI devices, Australia’s TGA reported the outcomes of its digital scribe review, and Japan issued its first SBOM guideline. Read on for more…
MedTech news from the EU
Team-NB assumes position on MDR and IVDR revision
On 8 October, Team-NB adopted a high-level position statement in support of the Commission’s proposal to revise the MDR and IVDR.
Team-NB calls for a balanced, risk-based approach that preserves notified body capacity, which it views as essential to avoid certification backlogs and to support innovation, SMEs, and timely patient access.
A day earlier, Team-NB published a separate position paper proposing that qualified notified body experts should contribute to the EMA expert panels, to clarify regulatory expectations and improve the quality of expert advice. Read the position statement here and the expert panel paper here.
Team-NB updates its IVDR certification process consensus document
On 6 October, Team-NB members adopted version 2 of their consensus document on the IVDR certification process.
The paper describes in detail how manufacturers move through the pre-application, application, and post-application phases when seeking notified body certification under Regulation (EU) 2017/746. As a common position amongst Team-NB members, it shows manufacturers what to expect from notified bodies at each stage. Read the document here.
MedTech news from the UK
UK confirms indefinite recognition of CE-marked devices
On 21 October, the UK Government confirmed its intention to recognise CE-marked medical devices and IVDs – certified under the MDR and IVDR – in Great Britain indefinitely.
For legacy devices certified under the Medical Devices Directive, GB recognition timelines are intended to follow the applicable MDR transitional arrangements. Eligible devices can continue to be placed on the GB market without an additional UK conformity assessment.
Conditions still apply however, including registration with the MHRA, a UK Responsible Person where required, and UK post-market surveillance obligations. Find out more here.
UK Government accepts all 44 recommendations on AI in healthcare regulation
On 6 October, the UK Government published its response to the National Commission into the Regulation of AI in Healthcare, accepting all 44 of its recommendations.
It commits to a proportionate, lifecycle-based approach to AI-enabled devices, including exploring staged authorisation pathways. The MHRA plan to share draft guidance on managing changes to AI-enabled devices in December 2026, consult on qualifying and classifying them in 2027, and will issue a full implementation roadmap in spring 2027.
The MHRA has also opened Phase 3 of its AI Airlock sandbox, which focuses on post-market surveillance, with applications received by 31 October considered in the current wave. Read the government response here.
MedTech news from the US
CDRH publishes FY 2027 guidance priorities
On 1 October, the FDA’s CDRH published its proposed guidance priorities for fiscal year 2027.
They are split into an A-list, a B-list and an “Under Construction” list, with software and AI featuring prominently. Planned documents include a final guidance on marketing submissions and lifecycle management for AI-enabled device software functions, a draft revision of the Policy for Device Software Functions, and a draft on postmarket cybersecurity management. CDRH is accepting comments on the lists until 30 November 2026. See the full list here.
FDA issues draft guidance on robotically assisted surgical devices
On 25 September, the FDA published draft guidance on premarket submissions for robotically assisted surgical devices (RASDs).
The draft covers device description, nonclinical testing (including teleoperation, kinematics, reliability, software and cybersecurity), clinical data, human factors, and labelling, and expects a validated training plan for operators and OR staff. Pre-operative planning systems, stereotaxic systems and robots that perform significant portions of a procedure autonomously fall outside the guidance scope.
The FDA has separately announced a public workshop on evaluating benefit-risk in robotic devices with autonomous or remote teleoperation capabilities. Read the draft guidance here.
FDA replaces “animal” with “nonclinical” testing terminology
On 22 September, the FDA issued a direct final rule, with a companion proposed rule, that replaces references to “animal” tests or studies with “nonclinical” tests or studies in certain safety and reporting sections of its regulations.
The rule defines “nonclinical test” and “nonclinical study” and uses “nonclinical” in place of “preclinical” and “in vitro” for consistency. The amendments align with recent changes to the FD&C Act and the PHS Act. They remove, in certain places, the emphasis on animal testing as the only scientific method for nonclinical safety assessment, and the FDA states they add no new requirements. Read the direct final rule here.
MedTech news from Asia Pacific
China consults on GMP inspection guidelines for standalone software and AI devices
On 30 September, China’s NMPA opened consultation on draft GMP inspection guidelines for standalone software, replacing its 2020 on-site inspection guidelines.
The draft sets out 203 inspection items, graded as critical, major, or general. They cover software development and testing, risk management, cybersecurity, supplier controls, software updates, release and post-market monitoring.
A week later, the NMPA’s CFDI followed with draft inspection points for AI medical devices. These expect a QMS suited to each product’s intended use, algorithm type, architecture, operating mode, and deployment environment. Read the software guidelines here and the AI inspection points here.
NMPA proposes simplified cross-provincial registration
On 29 September, the NMPA published draft provisions to simplify cross-provincial registration of medical devices that already hold a registration certificate.
The draft would make it easier for a related company in another province to register an existing domestic Class II or III device, including IVDs. Eligible applicants could reuse the original registration evidence where the product remains substantially unchanged, subject to current standards and quality system checks.
The measure implements the State Council’s 2024 opinions on deepening drug and device regulatory reform and supports a unified national market. Read the draft provisions here.
TGA finds most reviewed digital scribes likely to be medical devices
On 16 October, Australia’s TGA published the outcomes of its review of digital scribes supplied in Australia.
Of the 12 products reviewed, the TGA considered eight likely to include functions that meet the medical device definition, although none of the suppliers had classed their product as a device. The updated digital scribe guidance says tools limited to recording, transcribing, and structuring clinical conversations are not devices, while functions that analyse or interpret clinical information may be.
The TGA’s clinical decision support software guidance is now under review, and the reference to AI has been removed from its exemption criteria. Read the review outcomes here.
Japan issues SBOM guideline and PMD Act implementing ordinance
Last month, Japan’s MHLW issued version 1 of its guideline on introducing and operating software bills of materials (SBOMs) for medical devices.
The guideline takes a phased approach, advising manufacturers to first build the capability to produce and maintain SBOMs that meet minimum elements in SPDX or CycloneDX format, then integrate them with QMS and post-market processes such as vulnerability and end-of-support management.
On 30 September, MHLW also promulgated Ordinance No. 142, which updates implementing rules under the amended PMD Act (Law No. 37 of 2025), including requirements for quality and safety managers, manufacturing oversight, and supply chain management. Read the SBOM guideline here and the ordinance here.
That concludes our October 2026 MedTech news roundup. We’ll be back in November with more medical device news and updates.
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