Introduction: A Three-Year Checkup on the Global MedTech Landscape
Three years ago, an article called Pursuing Regulatory Compliance with Purpose described the growing gap between the pro-innovation view in the United States and the more cautious approach in the European Union. Since that 2022 review, the situation has changed even more. New technologies have matured, and important new laws have arrived, reshaping the whole landscape. Artificial Intelligence (AI) has moved quickly from a promising idea to a real tool in clinical use. At the same time, big actions like the EU AI Act and the US AI Action Plan have forced companies to rethink their strategies. This article revisits the US–EU regulatory scene and gives a current, evidence-based view of the main challenges and opportunities for MedTech in 2025.
Executive Summary
In 2025, the global MedTech regulatory scene shows a sharp and growing split between the United States and the European Union. This creates different strategic needs for innovators.
In Europe, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) are still a big challenge. The phased transition dates to 2027–2029 avoided an immediate market crisis, but also created a long period of complexity. The shortage of Notified Bodies remains a system problem, and manufacturers’ readiness is now seen as a key factor.
The European Commission is aware of these obstacles and is formally studying how to simplify the rules, which may lead to a future adjustment. The United States moves in the opposite direction with a strong pro-innovation policy, aiming to lead in AI. A clear example is the FDA’s final guidance on the Predetermined Change Control Plan (PCCP). This gives an iterative path for AI-enabled devices, very different from Europe’s heavier dual-certification process under both MDR and the new AI Act.
The US vs. EU Regulatory Divide: A Landscape of Diverging Philosophies
A significant difference in thinking and process separates the two largest MedTech markets. This gap directly affects how companies get market approval, how fast they can innovate, and how they plan their global strategy.
The U.S. Framework: A Pro-Innovation Stance
The U.S. Food and Drug Administration (FDA) is known as an active partner in technological progress. This view comes from a stable and well-known regulatory system, mainly the 510(k) pathway. This pathway asks a manufacturer to show “substantial equivalence” to a legally marketed device. The process is strict but seen by the industry as manageable and helpful for step-by-step innovation.
This pro-innovation attitude is now set in clear policy. The FDA has finalized guidance for Predetermined Change Control Plans (PCCPs) for AI devices. This gives a structured way to manage the evolution of adaptive technologies. With a PCCP, companies can make pre-approved changes without sending a new submission every time. This supports the fast development cycles of software and AI. Together with a national plan to speed AI progress by cutting heavy regulations, this positions the United States as a market that actively supports and drives technological growth.
The European Framework: A Precautionary and Complex Environment
In contrast, Europe’s system under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is complex and follows a precautionary approach.
For many devices, the EU path asks for proof of “exact equivalence,” which is a high barrier for new companies. These strict rules are made harder by a limited capacity of conformity assessment bodies, creating delays and extra costs. Because of this, market strategies have clearly shifted. The US now holds about 46.4% of the global MedTech market, while Europe is at 26.4%. A 2025 MedTech Europe survey shows that since MDR/IVDR started, the choice of the EU as the first launch market has dropped by around 40% for large IVD makers and 33% for large device makers. Although the EU system aims to give the highest safety, many in the industry see it as slowing innovation and making Europe less attractive as the first place to introduce new medical technologies.
EU MDR/IVDR Implementation: From Acute Crisis to Chronic Challenge
The biggest recent change in the EU is the new law to avoid the “cliff edge” of expiring certificates. Thousands of important medical devices were at risk of leaving the market, so the European Commission decided to extend the transition periods. Regulation (EU) 2024/1860 gives a step-by-step extension for legacy devices if manufacturers meet certain conditions.
High-risk devices (Class III and implantable Class IIb) must now comply with MDR by 31 December 2027. Lower-risk devices have until 31 December 2028. IVDs also received extra time, with new deadlines up to 31 December 2029 depending on risk class. The “sell-off” rule was removed, easing supply chain pressure.
These measures prevented a public health crisis but turned an urgent problem into a multi-year challenge. Recognizing the system’s limits, the European Commission launched a “Call for Evidence” in September 2025 to collect stakeholder ideas on how to simplify the rules and make them more predictable. This is an essential step toward possible reform.
Notified Body Capacity: A Stabilizing but Still-Constrained Ecosystem
The capacity of the EU Notified Body (NB) system is still a central problem. As of early 2025, there are 51 designated NBs, but this is not enough to handle all applications quickly. Data from mid-2025 shows a clear gap: more than 28,489 MDR applications were filed, but only 12,177 certificates were issued.
Most MDR submissions take a long time—about 13 to 18 months for 60% of cases from application to final certificate. New data gives a new perspective on what causes the bottleneck. An EU Commission survey found that manufacturers cause about 58% of the total processing time, mostly because of incomplete submissions. This means the delays come from both sides: insufficient NB capacity and inadequately prepared companies.
Strategic Implications for MedTech Innovators (2025–2027)
The divergent regulatory and policy landscapes demand a recalibrated global strategy for MedTech innovators. Navigating this environment requires a nuanced approach to market entry, product development, and long-term resource allocation.
The “US-First” Model Solidifies, Backed by a National AI Strategy
The strategy for global launch has now clearly moved to a “US-First” model, and this is backed by national policy. The 2025 America’s AI Action Plan treats AI leadership as a matter of national security. It tells federal agencies to speed innovation by removing heavy regulations and supporting private companies.
This strong top-down support gives a big push to innovators and stands in sharp contrast to the EU’s complex, multi-layered rules. For MedTech companies, this means a clear path: launch first in the United States to use the friendly regulatory climate, earn early revenue, and collect real-world evidence.
Navigating the Deepening AI/ML and Cybersecurity Regulatory Divide
The strategic divergence is most pronounced for AI-enabled and connected devices, where innovators face two distinct compliance fronts: AI governance and cybersecurity.
The AI Governance and Risk Management Chasm
Both the US and the EU are building systems to manage AI risks, but their methods are very different.
EU – Mandatory and Integrated
The EU AI Act sets a legally binding, risk-based framework that works together with MDR and IVDR.
Almost all AI medical devices are classed as “high risk.”
They must follow strict rules for risk control, data governance, human oversight, and transparency.
Risk management is a continuous process across the whole device life, based on ISO 14971.
Manufacturers can include these AI rules inside their existing quality system, but the need to comply with both MDR/IVDR and the AI Act is still a heavy load.
US – Voluntary and Flexible
In the United States, the National Institute of Standards and Technology (NIST) created the AI Risk Management Framework (AI RMF).
This is a voluntary guide to help organizations build trustworthy and responsible AI.
The framework uses four core steps: Govern, Map, Measure, and Manage.
It gives a flexible process to find, assess, and reduce AI risks, with a strong focus on building a culture of risk management.
For healthcare, the NIST AI RMF is useful for patient safety, regulatory needs like HIPAA, and ethical issues such as algorithm bias.
The Cybersecurity Compliance Front
Cybersecurity is now a critical and unavoidable part of medical device regulation in both the US and the EU.
United States – Lifecycle Approach
In June 2025, the FDA published updated guidance “Cybersecurity in Medical Devices” under Section 524B of the FD&C Act for “cyber devices.”
The guidance requires a Secure Product Development Framework (SPDF) so that security is built into every stage of the product life.
Premarket submissions must now include a full Software Bill of Materials (SBOM), strong vulnerability management plans, and detailed security testing records.
European Union – Multi-Layered Rules
In Europe, cybersecurity is covered by several laws. The MDR includes basic safety requirements in its General Safety and Performance Requirements (Annex I, 17.2 and 17.4) to prevent unauthorized access and IT threats.
These are supported by the NIS 2 Directive, which sets cybersecurity standards for critical sectors, and by the EU AI Act, which adds special rules for high-risk AI systems.
In addition, as of 1 August 2025, new mandatory cybersecurity rules in the Radio Equipment Directive (RED) will apply to all internet-connected radio devices, affecting many MedTech products..
The Path Forward in Europe: A Dual Strategy of Compliance and Engagement
Even with all its difficulties, Europe is still a key MedTech market and cannot be ignored. A good long-term plan should integrate careful preparation for the complex rules and active participation in the EU’s innovation programs.
First, companies must prepare for the double compliance of MDR/IVDR and the AI Act.
The Medical Device Coordination Group (MDCG) continues to publish guidance, including a new roadmap for AI medical devices, to explain how these rules work together. Second, innovators should connect with the EU’s broader plan to strengthen research and innovation.
The “Choose Europe” program, launched in May 2025 with a €500 million budget for 2025–2027, aims to make Europe the most attractive place for researchers.
For MedTech companies, this offers a valuable chance to access top talent and research resources, helping to balance the heavy regulatory demands.
Propelling Next-Generation Medical Devices
Despite the complex and diverging regulatory landscapes, the future of MedTech remains exceptionally bright. The pace of innovation continues to accelerate, driven by powerful trends that promise to make healthcare more personalized, accessible, and effective. Wearables, telemedicine, and personalized medicine are transforming patient care, fueled by advances in genomics and data analysis. Navigating this promising future requires more than just groundbreaking technology; it demands a deep understanding that the “device dossier is the product, and the actual device is just a side effect”. Success hinges on a robust submission strategy and a meticulous evidence trail.
This is where a strategic partner becomes an indispensable innovation facilitator. Expert partners can provide critical domain knowledge from the earliest concept phase through post-market surveillance, helping to steer design protocols, validate use-case feasibility, and implement the necessary quality management systems. Ultimately, the path to market is smoothest for those who focus on tangible medical benefits, viable real-world applications, and seamless integration into clinical workflows. As one expert noted, “a small piece of advice given early on can help clients avoid overinvesting in efforts that are not required at all”. By embracing this philosophy and leveraging strategic partnerships, innovators can successfully navigate the regulatory maze and deliver the next generation of transformative medical solutions that improve and save lives around the world.
“A small piece of advice given early on can help clients avoid overinvesting in efforts that are not required at all.”
Building better regulatory compliance with HTEC
HTEC combines industry knowledge, business perspective, and technology expertise to help MedTech innovators bring impactful products to market with confidence. From early concept through launch and post-market surveillance, we provide end-to-end support to ensure regulatory compliance every step of the way.
Reach out to us or connect with Milos Cigoj to explore how we can support your next product journey.
