Top Medical Device Regulations to Watch in 2026

The US remains the world’s largest medical device market. North America accounted for 38.17% of the global market in 2024, with the US market alone estimated at around $199 billion in 2025.

In 2026, ongoing regulatory updates in the US are expected to have a more visible impact on inspections, submissions and product planning. While only a few changes have firm effective dates, several other areas will draw close attention as the FDA continues to refine expectations for quality systems, cybersecurity and AI tools.

In our blog, we review some of the key US developments medtech teams will monitor in 2026, followed by a brief look at international milestones with firm 2026 timelines.

FDA’s Updated Quality System: QMSR Takes Effect

The FDA’s Quality Management System Regulation (QMSR) outlines how medical device makers must design, document and maintain products to ensure safety. It updates the long-standing Quality System Regulation by aligning it with ISO 13485:2016, the internationally recognized quality standard for medical devices.

QMSR will take effect on February 2, 2026. Inspections after that date will follow the revised Part 820 framework. Companies already aligned with ISO 13485 will find the transition straightforward, while others may need to update procedures, train teams and revise documentation to match the structure FDA will now expect.

Cybersecurity Expectations for Connected Devices

The FDA’s cybersecurity expectations apply to devices that are connected to networks or can receive software updates. Section 524B of the Federal Food, Drug and Cosmetic Act (FD&C Act) requires manufacturers to build security controls into design, manage vulnerabilities and maintain a software bill of materials, essentially an ingredient list for code. The FDA’s 2025 cybersecurity guidance expands on how these elements should appear in submissions and quality systems.

While the statute is already in effect, manufacturers expect these recommendations to feature more prominently in reviews going forward. Teams developing connected or software-driven devices may see cybersecurity considerations addressed earlier and more formally during development.

AI-Enabled Device Software: Continued Refinement

The FDA’s work on AI-enabled device software focuses on how companies train, validate, monitor and update AI models. Draft guidance and the FY 2026 guidance agenda outline expectations for describing datasets, assessing performance across patient groups and using Predetermined Change Control Plans (PCCP) to manage model updates.

In 2026, developers will likely continue aligning internal practices with evolving policy signals rather than responding to a single regulatory deadline.

Diagnostics and Lab-Developed Tests: A Pause While Policy Resets

Lab-developed tests (LDTs) are tests that clinical laboratories design, validate and use. These tests were expected to fall under expanded FDA oversight in stages, including some steps planned for 2026.

A federal district court vacated the 2024 LDT rule in March 2025 (meaning the rule was nullified and cannot be enforced). In September 2025, the FDA issued a new rule that restored the regulatory wording that existed before the 2024 update.

Because of these actions, the staged LDT timeline that would have added new requirements in 2026 is no longer in effect.

Global Watchlist

Several international regulatory developments also converge in 2026 and may influence global launch plans and evidence strategies.

European Union (EU)

The Medical Device Regulation (MDR) includes a 2026 milestone for certain Class III custom-made implantable devices. The EU AI Act will begin applying core requirements to high-risk AI systems in 2026.

Cybersecurity expectations are also evolving as the Cyber Resilience Act introduces vulnerability reporting requirements in late 2026, and the NIS2 Directive guides national cybersecurity rules for sectors including healthcare.

United Kingdom

The UK plans to introduce annual device registration fees starting in April 2026 as part of updates to how post-market oversight is funded. Companies operating globally may factor these administrative changes into their planning for the UK market.

All in all, 2026 might unfold into a year of implementation and alignment across quality systems, software oversight and global market readiness.

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