Regulatory updates

Regulatory updates for MedTech teams.

Selected EU and U.S. regulatory updates for medical-device, IVD, SaMD, and quality teams. Entries link to official sources and note the regulatory area affected.

Latest updates Sources followed

Latest updates

Latest regulatory updates

Recent FDA, EU MDR/IVDR, EUDAMED, QMS, and software updates with source links, dates, and the practical regulatory area affected.

FDA · QMSR · Effective February 2, 2026 Active

FDA QMSR and 21 CFR Part 820 harmonization

FDA's medical-device quality-system rule now aligns with ISO 13485:2016 through the Quality Management System Regulation, while retaining U.S.-specific requirements.

Source: FDA QMSR page and FDA QMSR FAQ
Date: Effective February 2, 2026
Jurisdiction: United States
Topic: QMSR, ISO 13485, 21 CFR Part 820

Planning check: Confirm whether ISO 13485-aligned procedures also address the U.S.-specific QMSR additions that remain in scope.

Official FDA QMSR page

EU · MDR / IVDR · Proposal published December 16, 2025 Watch

European Commission proposal to simplify MDR and IVDR rules

The Commission has proposed targeted changes to the EU medical-device and IVD framework, including measures connected to simplification and digital procedures.

Source: European Commission medical devices sector pages
Date: Proposal published December 16, 2025
Jurisdiction: European Union
Topic: MDR, IVDR, simplification, digitalisation

Planning check: Track whether the proposal changes certificate planning, EUDAMED sequencing, documentation timing, or economic-operator responsibilities.

European Commission new regulations page

EU · EUDAMED · Mandatory use from May 28, 2026 Prepare

EUDAMED mandatory-use timeline

The European Commission states that the first four EUDAMED modules are mandatory to use from 28 May 2026.

Source: European Commission EUDAMED overview
Date: Notice published November 27, 2025; mandatory use from May 28, 2026
Jurisdiction: European Union
Topic: Actor, UDI/device, certificate, and market-surveillance modules

Planning check: Identify who owns actor, device, UDI, certificate, and market-surveillance data before mandatory-use dates apply.

European Commission EUDAMED overview

FDA · AI / SaMD · Final guidance August 2025 Assess

FDA PCCP guidance for AI-enabled device software

FDA's final guidance describes marketing-submission recommendations for predetermined change control plans for AI-enabled device software functions.

Source: FDA final guidance
Date: Final guidance issued August 2025
Jurisdiction: United States
Topic: AI-enabled device software, PCCP, marketing submissions

Planning check: Define intended modifications, validation logic, and control boundaries before relying on a PCCP strategy.

Official FDA guidance

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