The week of 27 July–2 August 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors.
The main developments included new MHRA guidance on software qualification, an EU Court of Justice judgment on distributors’ MDR obligations, FDA’s FY 2027 medical-device user fees, a field safety notice concerning the GORE EXCLUDER TAMBE device, and updated UK safety guidelines for clinical MRI equipment.
In this issue
- MHRA issues guidance on ambient voice technology and updates digital mental health guidance
- EU Court of Justice clarifies MDR due-care obligations for distributors
- FDA publishes medical-device user fees for FY 2027
- GORE updates safety information for the EXCLUDER TAMBE device
- MHRA publishes fifth edition of MRI safety guidelines
MHRA Issues Guidance on Ambient Voice Technology and Updates Digital Mental Health Guidance
On 29 July 2026, the Medicines and Healthcare products Regulatory Agency published new guidance on the qualification and classification of ambient voice technology-enabled products. The agency also updated its existing guidance on digital mental health technologies.
MHRA states that ambient voice products intended solely for functions such as transcription, summarising clinical conversations, drafting correspondence or suggesting clinical codes for clinician review may fall outside medical-device regulation.
Products intended for diagnosis, treatment or prevention, or products that perform automated clinical actions, may qualify as medical devices depending on their intended purpose and functionality.
The digital mental health update adds clarification on when products do not qualify as software as a medical device. It also addresses accessories, interconnected or multi-module products, and EU MDR classification following MDCG 2019-11 Rev.1.
The two documents clarify the boundary between regulated medical-device software and non-device digital health functions.
Source: MHRA
Reference: 1) Ambient voice technology-enabled products, MHRA; 2) Digital mental health technology: qualification and classification, MHRA
EU Court of Justice Clarifies MDR Due-Care Obligations for Distributors
On 27 July 2026, the Official Journal of the European Union published notice of the Court’s judgment in Case C-10/24, Dürr Dental, delivered on 4 June 2026.
The case concerned distributors’ obligations under Article 14 of the MDR where a product had been CE-marked as machinery rather than as a medical device.
The Court held that a distributor must verify, based on the information available to it, whether the CE marking and EU declaration of conformity clearly concern a product falling within the scope of the MDR.
A distributor is not required to independently verify whether the device should be classified as Class IIa. However, where the manufacturer’s stated classification requires the involvement of a notified body, the distributor’s due-care obligation includes checking that the notified body’s four-digit identification number is indicated.
The judgment provides an EU-wide interpretation of distributors’ verification and due-care obligations under MDR Article 14.
Source: Court of Justice of the European Union
Reference: Case C-10/24, Dürr Dental — Judgment of the Court, First Chamber, 4 June 2026
FDA Publishes Medical-Device User Fees for FY 2027
On 30 July 2026, the U.S. Food and Drug Administration published the medical-device user-fee rates applicable during fiscal year 2027, from 1 October 2026 through 30 September 2027.
The annual establishment registration fee will be $13,785. The standard 510(k) fee will be $28,653, with a qualifying small-business fee of $7,163.
Standard De Novo fee will be $191,020, while the standard fee for a premarket application, including a PMA, PDP or BLA, will be $636,732.
The notice establishes the fees applicable to device establishment registration and premarket submissions during FY 2027.
Source: FDA
Reference: Medical Device User Fee Rates for Fiscal Year 2027, FDA
GORE Updates Safety Information for the EXCLUDER TAMBE Device
On 27 July 2026, the Italian Ministry of Health published a Field Safety Notice concerning the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis, or TAMBE.
The underlying Gore safety alert is dated 24 July 2026 and addresses branch-component occlusions observed during ongoing clinical follow-up, together with an update to the device’s instructions for use.
Through the available follow-up period of up to approximately three years, branch-component occlusions had been reported in 22 of 80 evaluable subjects. Reported clinical consequences included mesenteric ischaemia, renal failure requiring dialysis and deaths related to branch occlusion or target-vessel events.
The revised information highlights lower renal-branch primary patency in certain patients with renal artery diameters of 5 mm or less.
Gore stated that its investigation had not identified design or manufacturing deficiencies and that the overall benefit-risk profile remained favourable within the approved indication.
The notice adds longer-term clinical follow-up data and revised safety information for an endoprosthesis used in complex thoracoabdominal and pararenal aortic repair.
Source: Italian Ministry of Health / W. L. Gore & Associates
Reference: Urgent Medical Device Safety Alert — GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE), W. L. Gore & Associates / Ministero della Salute
MHRA Publishes Fifth Edition of MRI Safety Guidelines
On 30 July 2026, MHRA published the fifth edition of its Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use.
The 111-page document represents a full review and update of the previous edition.
The guidance covers MRI hazards, exposure management, governance and controlled access, emergency procedures, implanted medical devices, incident reporting, equipment maintenance and the wider equipment lifecycle.
This edition was rewritten with input from UK professional organisations and international MRI safety experts.
Updated guidance provides a comprehensive UK reference for MRI safety governance, clinical use, incident management and equipment lifecycle controls.
Source: MHRA
Reference: Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use, MHRA
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