Regulating AI in Medical Devices: FDA and EU Expectations by 2026

Artificial intelligence is transforming medical devices and digital health technology, and

regulators in both the United States and Europe are preparing new oversight frameworks

that will take effect by 2026. For companies using AI and machine learning, these updates

will significantly change how products are designed, validated, and maintained after market

clearance.

In Europe, the new AI Act classifies most AI based medical devices as high risk systems. By

August 2026, these devices must comply with new conformity assessments, transparency

rules, and risk management requirements. The AI Act builds on the MDR and IVDR by

adding obligations specific to algorithms, including bias control, human oversight, and

continuous monitoring of performance.

In the United States, the FDA continues to release new guidance documents for AI and

machine learning devices. One of the most important developments is the framework for

Predetermined Change Control Plans, which allow companies to make future algorithm

updates without new submissions, provided that the changes were pre approved as part of

the original application. The FDA is also working on new recommendations for

transparency, validation, and post market monitoring to ensure that learning algorithms

remain safe and effective over time.

For manufacturers, the key challenge is balancing innovation with regulatory control.

Companies should invest early in data governance, risk management, and human factors

validation to meet these new expectations. Developing internal AI quality procedures and

clear documentation will help avoid approval delays once the regulations take effect.

The next 18 months will set the stage for global AI regulation in medical devices.

Organizations that act now to align their design controls and data validation processes with

both FDA and EU requirements will be well positioned for success when the new rules

become enforceable.

If your team is developing AI or software based medical devices and needs help

understanding these evolving requirements, PRP Compliance can help you prepare for the

2026 regulatory landscape.