What Medtech Companies Can Expect in 2026: Regulation, Risk, and Resilience

The medical technology sector enters 2026 with strong fundamentals, sustained demand for innovative devices, and active dealmaking driven by technology advances, demographic pressures, and significant deployable capital. Going into 2026, high-quality, high-growth assets continue to command significant attention, and the competition for these assets is expected to intensify. Evolving frameworks in the European Union and United Kingdom, shifting enforcement priorities in the United States, and a rapidly changing global tariff landscape are influencing how in-house legal teams assess risk and structure transactions. This Insights summarizes key considerations legal teams may prioritize as complexity and scrutiny increase.

EU and UK Outlook: A New Regulatory Landscape for Devices

In the European Union and United Kingdom, medtech regulatory reform remains a defining factor for 2026 deal-making. Updates to device frameworks carry implications for diligence, valuation, and integration timelines.

A key consideration in acquisitions of EU-marked products is the changes to the EU regulatory framework and what this means for the status of certificates. Certificates of Conformity cannot simply be transferred to a new legal manufacturer as the assessment process includes consideration of the manufacturer’s quality management system. There are therefore important considerations for how such acquisitions are structured and whether, in an asset transfer, certificates must be reissued and Conformité Européenne (CE) marking reaffixed under the buyer’s name. This process can require significant time depending on device classification, dossier quality, and notified body availability. For deal teams, this introduces procedural complexity and timing risk, particularly where closing or integration assumptions are tied to regulatory approvals.

Further, under the new regime, all devices have to be recertified under the new rules. There are transition provisions in place, but again, companies need to assess the continued validity of certificates and compliance with the relevant requirements to ensure the continued availability of products in the UK.

Post Brexit, the UK is also reassessing its regulatory framework, and a new regime is likely to be introduced this year. As part of such regime, the UK proposed an international reliance framework that could be an important commercial strategy for companies. With comparator regulators such as Australia, Canada, the EU, and the United States to become part of the scheme, companies may benefit from streamlined approvals, but these efficiencies still require careful mapping across jurisdictions. Buyers evaluating multinational device platforms must understand how reliance mechanisms will operate in practice and the conditions to be met.

EUDAMED and the Transparency Shift

Transparency continues to expand across the EU regulatory system, which in the EU at least, is a new dimension to the devices framework. In late 2025, the European Commission confirmed the functionality of four key European Database on Medical Devices (EUDAMED) modules, which will become mandatory from May 28, 2026. Companies must ensure device data is complete, accurate, and validated (including information related to third-party devices) before the deadline.

With more information entering the public domain, buyers may gain clearer visibility into device status, certification history, and surveillance outcomes. At the same time, expanded data availability could increase litigation exposure from competitors and heightens the importance of accuracy and traceability.

US Enforcement Priorities: A New Phase for Regulatory Diligence

Medtech companies supplying the US marketplace are navigating a regulatory environment that is becoming more active, device-specific, and consequential for transaction planning. With medtech companies continuing to participate in the Medical Device Single Audit Program (MDSAP), the US Food and Drug Administration (FDA) is able to redirect its resources to better focus on patient safety issues. FDA is now more efficiently mining post market data to identify trends and signals, resulting in companies being sent requests for additional information. In addition, FDA is sending its FDA investigators both domestically and abroad to companies that are associated with patient safety signals. These developments require reassessment of quality systems, documentation, and surveillance functions. For deal teams, this may mean additional diligence tied to recalls, inspection history, and responsiveness to regulatory feedback.

This trend is reinforced by product-level divergence across the sector. Clinical and technological innovation (especially in data-driven, robotic, and software-enabled devices) is generating differentiated regulatory frameworks, evidence expectations, and risk profiles. FDA is also continuing to refine its approach to consumer digital health technologies. Recent signals from the agency suggest that FDA may be more willing to view consumer health products as unregulated general health and wellness products (see our recent LawFlash). These product-specific dynamics can influence pathway timing, valuation, milestone structuring, and integration planning, underscoring the need for tailored diligence.

With deployment of the Quality Management System Regulation (effective February 2, 2026) replacing the legacy Quality System Regulation, FDA will be expecting that companies better integrate and utilize risk management within their quality system. In addition, FDA will be evaluating a company’s “quality culture”—making sure that personnel within the quality system are empowered to make decisions that protect patient health and safety.

Against this backdrop, expect a continued increase of enforcement from FDA. Diligence should not only focus on companies having compliant processes and procedures, but that execution is resulting in sound decision-making.

Tariffs, Trade, and National Security: A Reshaped Global Supply Chain

The US trade landscape shifted materially in February 2026 when the US Supreme Court held that the International Emergency Economic Powers Act (IEEPA) does not authorize the president to impose tariffs, invalidating the IEEPA-based tariffs imposed in 2025. The decision narrows the executive branch’s emergency tariff authority and removes a significant source of unilateral trade risk for import-reliant industries, including medtech.

However, the ruling does not resolve commercial uncertainty. The Court did not address how refunds will be administered, and the administration has signaled that it may rely more heavily on alternative statutory authorities going forward, including Sections 301, 232, and 122 of the Trade Act. Ongoing or future national security investigations into medical products and related supply chains, including the pending Section 232 investigation of medical equipment and devices, could still result in targeted duties or quotas.

For acquirers, the practical implication is a shift from broad emergency-based tariff risk to more statute-specific exposure. Diligence should assess country-of-origin, product classification (including potential tariff relief pursuant to secondary tariff classifications in Chapter 98 of the Harmonized Tariff Schedule of the United States), customs compliance history, and documentation necessary to pursue potential refunds. Valuation models should also reflect the possibility of new duties under alternative authorities and the cost of supply chain adjustments. While the Supreme Court’s decision curtails one avenue of tariff expansion, trade volatility remains a strategic consideration. Medtech companies operating global manufacturing and sourcing models should continue to build flexibility into pricing, contracting, and integration planning.