In the United States, the Food and Drug Administration (FDA) regulates medical devices through its Center for Devices and Radiological Health (CDRH). But regulation doesn’t stop at U.S. borders. Every major market has its own regulatory body, and a device sold internationally may need separate approval from agencies in Europe, the UK, Canada, Australia, and beyond.
The FDA’s Role in the United States
The CDRH is the specific arm of the FDA responsible for ensuring that medical devices and radiation-emitting products are safe, effective, and high quality. It oversees everything from tongue depressors to artificial hearts, sorting devices into three risk-based classes that determine how much scrutiny they receive before reaching patients.
Class I covers the lowest-risk devices, things like bandages and manual stethoscopes. These face basic regulatory controls and are often exempt from a formal review process. Class II includes moderate-risk devices like powered wheelchairs and pregnancy tests. These typically require what’s called a 510(k) submission, where the manufacturer demonstrates the device is “substantially equivalent” to something already on the market. The FDA reviews the scientific evidence, which can include clinical data, engineering performance testing, biocompatibility evaluations, and software validation.
Class III is reserved for the highest-risk devices, such as implantable pacemakers and replacement heart valves. These require Premarket Approval (PMA), a much more rigorous process involving extensive clinical trial data proving the device is safe and effective on its own merits, not just compared to a similar product.
What It Costs to Get FDA Clearance
The FDA charges user fees for device submissions, and they’re not trivial. For fiscal year 2026, the standard fee for a 510(k) submission is $26,067. Small businesses certified by CDRH pay a reduced rate of $6,517. For a PMA application, the standard fee jumps to $579,272, with a small business rate of $144,818. These fees cover the cost of the FDA’s review but don’t include the manufacturer’s own expenses for testing, clinical trials, and documentation, which can dwarf the filing fees themselves.
How Europe Regulates Devices
The European Union uses a fundamentally different model. Rather than a single government agency reviewing every device, the EU relies on independent organizations called Notified Bodies to assess whether devices meet regulatory requirements. These Notified Bodies, such as TÜV SÜD, are designated by national authorities and verified by the European Commission. As of May 2025, 50 Notified Bodies are designated to evaluate medical devices under the EU’s current framework.
That framework is the Medical Device Regulation (MDR), which came into full effect in May 2021 and replaced an older system of directives. The MDR significantly raised the bar for evidence and documentation. Notified Bodies audit manufacturers’ quality management systems, assess technical documentation, and verify that devices meet general safety and performance requirements. Only after this process is complete can a Notified Body issue an EU certificate allowing the manufacturer to sell the device across EU member states.
The transition has not been smooth. Many manufacturers have struggled with the increased evidence requirements, and limited Notified Body capacity has created bottlenecks. The European Commission has responded by extending transition deadlines, with staggered timelines running to December 2027 for higher-risk devices and December 2028 for others.
The UK’s Post-Brexit Path
Since leaving the EU, the United Kingdom has been building its own regulatory framework under the Medicines and Healthcare products Regulatory Agency (MHRA). During the transition period, the UK has continued recognizing CE-marked devices (those approved under the EU system), and as of early 2026, the government was consulting on whether to recognize CE marks indefinitely in Great Britain.
The MHRA introduced updated post-market surveillance requirements in June 2025 and plans to follow with new pre-market requirements in 2026. These upcoming rules will introduce unique device identifiers, strengthen technical documentation requirements, and create an international reliance scheme that would allow faster access for devices already approved by comparable regulators elsewhere. The government has emphasized a phased approach to avoid disrupting the supply of devices to UK patients.
Canada and Australia
Health Canada regulates medical devices sold in Canada, requiring manufacturers to obtain a device license before marketing their products. Australia’s equivalent is the Therapeutic Goods Administration (TGA), which operates under the Therapeutic Goods Act 1989. Both agencies maintain their own review processes and classification systems.
The two countries have a mutual recognition agreement that allows them to share manufacturing compliance certifications, reducing duplication of inspections for pharmaceutical facilities. This kind of cooperation reflects a broader trend among regulators toward recognizing each other’s work rather than requiring manufacturers to repeat identical assessments in every market.
Global Coordination Through IMDRF
Because regulatory requirements vary from country to country, medical device regulators from around the world participate in the International Medical Device Regulators Forum (IMDRF). This voluntary group develops internationally agreed-upon guidance documents on topics ranging from device classification to clinical evidence requirements. Member regulators then adopt or adapt these documents to fit their own systems.
One of IMDRF’s most consequential contributions has been creating a common framework for software-based medical devices. Health apps, AI diagnostic tools, and clinical decision-support software don’t fit neatly into traditional device categories designed for physical hardware. In 2013, an IMDRF working group chaired by the FDA developed shared definitions, risk categories, quality management standards, and clinical evaluation guidelines specifically for software that functions as a medical device without being part of a physical product.
The FDA has since built on this foundation with specific guidance for AI and machine learning in medical devices, covering topics like transparency, good development practices, and how manufacturers can plan for software updates that change how an algorithm performs over time.
What Happens After a Device Reaches the Market
Regulation doesn’t end at approval. In the U.S., manufacturers are legally required to report to the FDA when they become aware that one of their devices may have caused or contributed to a death or serious injury, or when a malfunction occurs that could lead to death or serious injury if it happened again. These reports must be filed within 30 calendar days.
The timeline tightens dramatically when public health is at stake. If a reportable event requires the manufacturer to take corrective action to prevent substantial harm, a report is due within five working days. The same five-day window applies if the FDA specifically requests an expedited report. Manufacturers must also file supplemental reports within 30 days whenever they learn new information that wasn’t available in the initial filing.
The EU’s MDR similarly strengthened post-market surveillance requirements, requiring manufacturers to actively monitor device performance and report serious incidents. The UK’s MHRA introduced its own updated surveillance rules in 2025, signaling that regulators worldwide are placing increasing emphasis on what happens with devices after they’re in patients’ hands, not just before.