Strengthening Device Cybersecurity: 2026 Requirements in the US and EU

Cybersecurity has become a top regulatory priority as medical devices become more

connected and software driven. By 2026, both the FDA and the European Union will have

new requirements that manufacturers must meet to ensure devices remain secure

throughout their lifecycle.

In the United States, recent legislation now requires that every new FDA device submission

include a detailed cybersecurity plan. This plan must describe how the manufacturer

identifies vulnerabilities, manages risks, and maintains the device through security updates

and patches. The FDA’s final guidance emphasizes the need for a software bill of materials,

clear threat modeling, and documented evidence that cybersecurity controls are integral to

the device’s design. Failure to address these expectations can delay or even prevent product

approval.

In Europe, cybersecurity obligations are expanding under the MDR and IVDR.

Manufacturers must show that cybersecurity is addressed from the design stage through

post market surveillance. The EU’s NIS2 Directive further strengthens requirements for

critical infrastructure, including medical device manufacturers and suppliers. These updates

mean that companies must demonstrate a proactive approach to both product and

organizational cybersecurity.

Manufacturers should act now to establish a comprehensive cybersecurity management

plan. This includes performing security risk assessments, integrating secure coding

practices, monitoring emerging vulnerabilities, and maintaining procedures for timely patch

deployment. Establishing clear responsibilities within the quality management system will

also help satisfy both FDA and EU expectations.

Cybersecurity is no longer optional for regulatory compliance. By 2026, regulators will

expect it to be built into every device and documented as part of safety and performance.

Companies that plan ahead will protect not only patients and data but also their market

reputation and approval timelines.

If your team needs support developing or validating your medical device cybersecurity

strategy, PRP Compliance can help you align with both FDA and EU requirements before the 2026 deadlines.