Welcome to this fortnight's SMEDTEC Intelligence. The period has been unusually busy across all three major markets. FDA has pushed through a cluster of new Class II device classifications—each creating a 510(k) pathway with defined special controls—while MHRA has published long-awaited qualification and classification guidance for ambient voice technology and digital mental health tools, and refreshed its entire clinical investigation framework for Great Britain. On costs, FDA's FY2027 MDUFA V user fee schedule is now final. Safety teams should note the expanded Dräger Atlan Field Safety Notice. Read on for the details that matter most to your programmes.
The fortnight in numbers
By market
By regulator
Upcoming deadlines
Competitor approvals · last 30 days
By regulator
By market
FDA · US
The official fee schedule for FY2027 (starting 1 October 2026) is now set under MDUFA V. Regulatory teams and finance colleagues should update submission budgets immediately—510(k), PMA, De Novo and establishment registration fees are all affected. Planning any US submissions for Q4 2026 or beyond without these figures risks budget surprises.
Read the source →MHRA · UK
MHRA, working with NHS England, has published qualification and classification guidance for ambient voice technology products—AI-driven tools that passively capture and document clinical encounters. Manufacturers of AVT, voice-to-text, and related software-as-a-medical-device (SaMD) products now have a clear MHRA framework for determining whether their product is a regulated medical device and, if so, its class under UK MDR 2002. This fills a significant grey area and may trigger conformity-assessment obligations for products already deployed in the NHS.
Read the source →MHRA · UK
Alongside the AVT guidance, MHRA has released a parallel document for digital mental health technology, helping manufacturers determine whether their product qualifies as a medical device and how it should be classified. Together these two publications represent MHRA's most significant SaMD/DTx policy output of 2026 and are essential reading for any company operating in the digital health, wellness, or therapeutic software space selling into Great Britain.
Read the source →MHRA · UK
MHRA has simultaneously updated four interlinked guidance documents covering: (1) which devices need a clinical investigation, (2) how to compile and submit a notification, (3) the approval process, and (4) the overarching regulatory requirements for conducting investigations in GB. Manufacturers planning or running clinical investigations under UK MDR should review all four documents as a package—changes to submission requirements or exemption criteria could affect live programmes.
Read the source →FDA · US
FDA has formally classified the diabetes digital behavioral therapeutic device into Class II with special controls, creating an established 510(k) pathway for this product type. This is a landmark classification for the digital therapeutics sector: manufacturers of prescription or OTC diabetes management apps with a behavioral-intervention mechanism now have regulatory clarity on the pathway, performance testing, and labelling requirements needed for US market clearance.
Read the source →FDA · US
The formal Class II classification of OTC SARS-CoV-2 tests from clinical specimens sets permanent special controls—replacing the emergency-use framework many manufacturers relied upon. Companies with legacy EUA-based products or pipeline tests must now map their technical documentation and performance data against the codified special controls to maintain or obtain 510(k) clearance. This also signals FDA's intent to normalise the IVD pathway for pandemic-era diagnostics.
Read the source →MHRA · UK
MHRA has opened a call for AI-enabled medical device manufacturers and NHS provider organisations to participate in its London Region I Regulatory Sandbox. This is a rare direct route to regulatory dialogue with MHRA during product development, potentially reducing time-to-market and shaping future policy. Small and mid-size innovators in AI diagnostics, imaging, or clinical decision support should strongly consider applying before the window closes.
Read the source →MHRA · UK
Dräger has expanded the scope of its Field Safety Notice (DSI/2026/005) for Atlan anaesthesia workstations to cover additional affected serial numbers following identification of a manufacturing defect that could cause mechanical ventilation failure. Regulatory and post-market surveillance teams at manufacturers of similar capital equipment should use this as a benchmark case for their own FSCA scope-expansion procedures. Healthcare facility customers may also seek information from device suppliers about comparable vigilance processes.
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