Regulatory Changes in MedTech: 3 Shifts Executives Must Be Aware of in 2025

When MedTech companies run afoul of regulations, the consequences can cripple their growth for years. 

Take Olympus—they were penalized for currying favor with doctors with international travel, expensive business meals, and consulting payments, ending in a $646 million settlement—the largest amount ever paid for breaking anti-kickback laws in the USA.  

And Olympus is far from alone. Pentax paid $43 million in 2020 after deliberately avoiding FDA-cleared cleaning instructions because the new protocols took 25 minutes instead of five. They chose faster turnaround times over compliance due to concerns about losing customers to competitors. 

Why bring up these old stories? Because in 2025, the regulations that ensnared these companies are getting tougher, and the stakes are higher than ever. Here’s what’s changing: 

1. Global Harmonization Efforts Gain Momentum 

The International Medical Device Regulators Forum (IMDRF) is making progress in synchronizing regulatory standards worldwide.  

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is implementing a new regulatory framework, with core elements intended to be in place by 2025. This framework aims for greater international harmonization while keeping patient safety at the forefront. 

Global harmonization in general is becoming central to the Life Sciences and Healthcare sector, with major regulatory bodies working together. For example, the FDA and European Medicines Agency are collaborating through the International Coalition of Medicines Regulatory Authorities to develop a global Pharmaceutical Quality Knowledge Management System, with Japan’s medical device agency participating as an observer.  

This unified approach means consistent standards across markets—but it also means future violations in one region could affect a company’s standing everywhere. 

2. AI and Machine Learning Regulations Mature 

The integration of AI into medical devices has triggered a wave of new regulations worldwide. The EU led the charge with its AI Act in August 2024, classifying most AI-enabled medical devices as high-risk. This classification demands that companies prove their AI systems are secure, accurate, and transparent before they can reach the market.  

Following Europe’s lead, the FDA is creating comprehensive guidelines for 2025 that focus on two critical aspects: how to manage AI systems throughout their lifecycle and what companies must show in premarket submissions. The key innovation here is the predetermined change control plan (PCCP)—a framework that lets AI systems evolve and learn while keeping them safe.  

Health Canada is also building on these approaches, adding specific requirements about bias testing and ensuring training data represents diverse populations.  

3. Cybersecurity Remains a Top Priority 

The numbers are terrifying: cybercrime will cost the world $10.5 trillion yearly by 2025, jumping 15% each year. As a result of this, Gartner predicts that by 2025, a third of all countries will have laws specifically about ransomware payments, and that as time passes, threat actors might actually cause human casualties by weaponizing operational technology environments.  

In response, governments worldwide have rolled out tough new requirements. In the US, the FDA updated its cybersecurity guidance for medical devices while the Healthcare Cybersecurity Act was proposed in 2024 as another measure to tackle the problem.  

The EU integrated cybersecurity measures into both its Medical Devices Regulation and In Vitro Diagnostic Regulation, alongside the broader GDPR framework. In 2022, it also proposed the Cyber Resilience Act to further fortify its corporate cybersecurity. 

More changes are coming in 2025, including the UK’s new Cyber Security and Resilience Bill and China’s Network Data Security regulations.  

The moral of the story? From 2025 onwards, connected medical devices need to be bulletproof against both hijacking attempts and data breaches—and MedTech companies are finding themselves responsible not just for device safety, but for protecting entire networks of patient data. 

How to Deal with MedTech Regulations in 2025 

2025 will herald exciting new technologies in medical devices, especially in AI and connected healthcare solutions. However, these innovations come with heightened regulatory oversight and expanded responsibilities for Life Sciences and Healthcare organizations.  

MedTech companies that don’t prioritize regulatory compliance may face severe penalties from increasingly coordinated regulatory bodies worldwide. 

About the Author

Gavin McCartney, a Partner at Stanton Chase London, serves as the Global Sector Leader for the Health and MedTech sector. He brings extensive experience managing executive search assignments for clients at global, regional, and local levels, conducting searches across Europe, US, Africa, the Middle East, and Latin America.    

Gavin’s international executive search expertise includes working with multicultural teams in the life sciences and healthcare industry. He handles mandates ranging from C-suite to VP and director positions across various functional areas. Furthermore, complementary to mature global MedTech organizations, Gavin’s experience extends to supporting early to commercialized-stage start-ups and SMEs, navigating the unique challenges of small, fast-growing, and investor-backed organizations.