THE SYBEY BRIEFING

Regulatory intelligence.
A clearer perspective.

Recent developments in medical devices, clinical affairs and AI.
The update, its relevance, and a practical point to review.

Editorial review: EU & US focus

IN FOCUS · AI & SOFTWARE

Generative AI: help shape the regulatory conversation

FDA is seeking feedback on risk assessment, premarket evaluation and postmarket monitoring for generative AI-enabled medical devices. This discussion paper is neither draft nor final guidance and introduces no policy changes.

FDA · Generative AI discussion paper

RECENT UPDATES

What deserves
your attention.

US · QUALITY & INSPECTIONS
In effect

FDA QMSR: prepare for the updated inspection process

FDA began using its QMSR-aligned inspection process on 2 February 2026, replacing the Quality System Inspection Technique (QSIT). Inspections now follow Compliance Program 7382.850.

Why it matters & what to review

Why it matters

Manufacturers need to understand how their quality-system evidence will be reviewed under the updated FDA inspection approach.

What to review

Review Compliance Program 7382.850 with your quality and regulatory teams and update inspection-readiness activities against the current requirements.

Suggested review points from SYBEY.
FDA · Quality Management System Regulation
US · DIGITAL HEALTH
Resource update

FDA refreshes its AI-enabled device resource

FDA’s September updates include its list of AI-enabled medical devices. The resource links to public information about devices authorised for the US market; FDA notes that it is not exhaustive.

Why it matters & what to review

Why it matters

It offers a useful starting point for understanding the authorised-device landscape and available public evidence.

What to review

Review relevant device entries and their underlying decision summaries. A listing is not a substitute for assessing your own regulatory pathway.

Suggested review points from SYBEY.
FDA · AI-enabled medical devices
US · AI & SOFTWARE
Discussion paper

Generative AI: help shape the regulatory conversation

FDA is seeking feedback on risk assessment, premarket evaluation and postmarket monitoring for generative AI-enabled medical devices. This discussion paper is neither draft nor final guidance and introduces no policy changes.

Why it matters & what to review

Why it matters

Developers can contribute practical experience while regulatory approaches are being discussed.

What to review

Review the paper with regulatory, clinical and software teams. Consider a focused response to the questions most relevant to your experience.

Suggested review points from SYBEY.
FDA · Generative AI discussion paper
EU · UDI & QUALITY
Position paper

UDI assignment: keep manufacturer responsibility clear

MDCG 2026-5 clarifies UDI assignment where a device is marketed under manufacturer and distributor brands. Codes must remain linked to the manufacturer; practical tasks may be delegated without transferring its legal responsibility.

Why it matters & what to review

Why it matters

Branding arrangements can create inconsistencies between labels, UDI issuing-entity records and EUDAMED registrations.

What to review

Review distributor agreements and check which legal entity is linked to each UDI-DI across your records.

Suggested review points from SYBEY.
MDCG · 2026-5 position paper (PDF)
EU · CLINICAL AFFAIRS
Position paper

EUDAMED: review your safety and performance summaries

For medical-device teams, MDCG 2026-4 addresses management of summaries of safety and clinical performance (SSCPs) after mandatory use of EUDAMED.

Why it matters & what to review

Why it matters

Teams managing these summaries need to coordinate clinical documentation with their EUDAMED processes.

What to review

Review the position paper with your regulatory and clinical teams and identify the applicable workflow for your devices.

Suggested review points from SYBEY.
European Commission · MDCG guidance register
US · SUBMISSIONS
Final guidance

Human factors: align the evidence in your submission

FDA’s final guidance sets out a risk-based framework for human-factors information in device marketing submissions, including 510(k), De Novo, PMA and HDE applications.

Why it matters & what to review

Why it matters

A well-structured usability evidence package helps reviewers understand how use-related risks have been addressed.

What to review

Check your submission plan against this guidance and its companion on human factors and usability engineering.

Suggested review points from SYBEY.
FDA · Human factors submission guidance

Source dates are shown on each brief. Review points are SYBEY’s editorial suggestions.

KEEP WATCHING

Go straight
to the source.

For releases after our latest editorial review, consult these official update pages.

European CommissionMedical-device news and announcements
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MDCG guidance registerCurrent guidance and document revisions
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FDA · CDRH updatesDevice guidance, policy and safety news
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Curated and reviewed on 11 September 2026. This page is not an automatic news feed. Guidance, position papers and discussion documents have different regulatory status; consult the linked source for its scope and current version.

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