What U.S. Manufacturers Need to Know About EU’s Medical Device Rules Fix

For years, U.S. medtech companies eyeing the European market have had one recurrent complaint: The EU’s regulatory system for medical devices was too slow, too complex, and too unpredictable. They weren’t wrong. But the system is now changing—faster than many realize.

In December 2025, the European Commission issued a sweeping legislative proposal to simplify the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Alongside this medium-term overhaul, Brussels has already been delivering short-term fixes: a draft implementing act to make Notified Body assessments more predictable, new guidance to create a dedicated pathway for breakthrough innovations, and, more recently, an initiative to compile a robust list of well-established technologies. Together, these moves demonstrate that Europe is serious about becoming a more efficient, predictable market in which to commercialize medical devices.​

Why It Matters for U.S. Companies

The European Union is the world’s second-largest medical device market, worth roughly €170 billion in 2024, trailing only the United States. More than 38,000 companies operate in the sector, and 90% of them are small and medium-sized businesses. For U.S. manufacturers, Europe has long been a critical market, but one that became significantly harder to navigate after the MDR and IVDR took effect in 2021 and 2022, respectively.​

Those regulations replaced an older, more permissive framework and introduced stricter safety requirements, more robust clinical evidence standards, and tighter oversight. Think of it as Europe’s equivalent of the U.S. Food and Drug Administration (FDA) tightening its premarket notification 510(k) and Premarket Approval (PMA) processes simultaneously, but applied across 27 countries at once, with independent third-party organizations called “notified bodies” (analogous to FDA-recognized accredited testing labs, but with a much broader gatekeeping role) responsible for certifying that devices meet the new standards.​

Initially, the lack of notified body capacity created a real certification bottleneck—as more notified bodies came online, and certificates were issued, the structural problems of the regulation became apparent. The heavy administrative workload even for devices already in routine clinical use and the challenge of approving critical, low-volume technologies such as breakthrough, orphan, and pediatric devices had a particularly strong impact on small and medium-sized companies. In a statement released by MedTech Europe, the industry’s main European trade association, the message was clear: the regulations’ “structural deficiencies have led to serious unintended consequences.”

What Europe Is Doing Now: Short-Term Measures

While the broader legislative revision works its way through the EU’s co-legislative process, the European Commission has been delivering practical fixes that take effect much sooner.

• Implementing act on notified body assessments. One of the biggest complaints from manufacturers has been the unpredictability of the certification process: How long will it take? How much will it cost? The Commission has drafted an implementing act (essentially a binding administrative rule that doesn’t require full parliamentary approval) to set maximum assessment timelines for certification, recertification, and change control. It will also provide transparency from notified bodies about the total cost and time of review. For U.S. companies accustomed to the FDA’s structured review timelines (the 90-day 510(k) clock, the 180-day PMA review period), this is Europe moving toward a similar model of predictability. This implementing act is expected to be adopted by June 2026. 
• Guidance on breakthrough innovation. The Commission has also issued guidance allowing for the qualification and assessment of breakthrough innovation devices. U.S. audiences will recognize the concept from the FDA’s own Breakthrough Device Designation program, which provides more intensive interaction and prioritized review for technologies that offer significant advantages. The European Commission is expected to soon pilot the concepts in its guidance, opening the door for innovative companies to receive early regulatory feedback and potentially faster market access.

The Medium-Term Overhaul

In December 2025, the European Commission adopted a targeted legislative proposal to simplify specific IVD and MD requirements that were creating unnecessary administrative burden. This revision proposal is the centerpiece of Europe’s reform effort. It amends both the MDR and IVDR simultaneously and must still undergo a lengthy process in which it will be discussed and approved by both the European Parliament and the Council of the EU (representing national governments) before entering into force. 

The proposal’s key reforms cluster around several themes:

• Simplification measures: Reduction of administrative burden pre- and post-market is perhaps the most consequential change for manufacturers. While keeping the general safety and performance requirements intact, the revision sets out more risk-based rules. The proposals introduce several practical fixes to streamline the system. They call for structured dialogues between manufacturers and notified bodies, a lighter and more targeted review of technical files for mid- and lower-risk devices, and replacing fixed CE certificate expiry dates with ongoing, periodic assessments. Reporting requirements would also be eased, moving from annual to twice-yearly updates, while unannounced audits would become a strictly “for cause” tool. Conformity assessment would be simplified as well: near-patient IVD tests would be treated like other professional-use tests, and notified body involvement in certifying reusable surgical instruments would be significantly reduced. It also proposes coordinated EU-level oversight of notified bodies, harmonizing practices that currently vary from one EU country to another. 
• Innovation pathways: The proposal creates formal pathways for breakthrough technologies and orphan devices (those serving small patient populations, such as rare disease or pediatric patients). Regulatory sandboxes would be established at EU level: controlled testing environments where innovative products, including AI-based devices, can be validated under regulatory supervision without immediately facing full conformity assessment. This mirrors the FDA’s growing use of pre-certification concepts and real-world evidence frameworks for digital health technologies.​​
• International cooperation: The revision empowers the European Commission to recognize trusted third-country assessments, reducing duplicative audits for manufacturers who already hold clearances from regulators in markets like the U.S., Japan, or Australia. This aligns with the work of the International Medical Device Regulators Forum (IMDRF), where both FDA and European authorities participate. For U.S. companies, this could eventually mean that an FDA clearance carries more tangible weight in the European certification process.​
• Reduced administrative burden: Certificates would have longer validity, reporting requirements would become more risk-based, and electronic instructions for use would replace paper-based systems. The Commission projects these reforms will save approximately €3.3 billion per year, including €2.4 billion in administrative costs alone.​​

• Clearer rules for AI-based devices: The proposal clarifies how the MDR/IVDR interact with the EU’s AI Act, eliminating overlapping compliance requirements that have created confusion for manufacturers of AI-enabled diagnostics and devices.

Why This Time May be Different

Skeptics might note that Europe has struggled with the Medical Devices and IVD Regulations for years. But several factors suggest real momentum. The European Parliament called for urgent MDR/IVDR revisions in an October 2024 resolution. EU health ministers have echoed the call in successive Council meetings. The Commission’s own evaluation confirmed the regulations are not working as intended and are “undermining healthcare quality and patient safety,” an unusually blunt admission. Even the timeline is ambitious: most simplifications would apply just six months after the revised regulation is approved.​

​There is an urgent need to fix parts of the EU regulatory system that are clearly not working for patients, innovators, and healthcare providers. The proposal is a necessary step that has been a long time in coming. This is Europe’s chance to lead again and make sure innovative medical technologies reach patients on time.

The Bottom Line for U.S. Manufacturers

Europe’s medical device regulatory system is not standing still. The combination of immediate practical measures and a comprehensive legislative overhaul marks a clear direction: simpler, more proportionate—and critically—more predictable. For U.S. companies that have delayed or deprioritized European market entry, this is the moment to re-engage and start planning for a regulatory environment that will look substantially different within the next two to three years.

Petra Zoellner directs MedTech Europe’s team focusing on implementing EU regulatory systems for medical devices and in-vitro diagnostic products. She represents MedTech Europe to external fora on strategic regulatory policy questions, including the Medical Devices Coordination Group. She also acts as part of MedTech Europe’s leadership team, ensuring collaboration and coherence on topics that cross over to other areas in the medtech ecosystem. Since Zoellner joined MedTech Europe in February 2012, her work has involved leading and representing the association on regulatory policy in various domains, including implementation of the IVD Regulation, CE-marking topics, device labelling, trade in animal by-products, European database, medical technology standards, and regulation of substances and electronic devices, amongst others. Before MedTech Europe, Zoellner worked for the American Chamber of Commerce to the EU (AmCham EU), where she led the policy team handling legislative and regulatory issues. She also worked within the government affairs team of Genzyme.