Complying with the US FDA and EU MDR requires software updates

Software updates play a key role in ensuring the safety of connected medical devices. Timely and successful software updates directly affect patient safety, regulatory compliance, and brand reputation. Managing software updates in compliance with the US FDA and EU MDR demands adherence to design controls, effective risk management, robust cybersecurity measures, and comprehensive post-market surveillance. The complexity of complying escalates for high-risk devices, devices with a significant potential impact on patient safety.

Whether deploying a critical security patch or rolling out new features across a fleet of connected products, OEMs must understand and implement a strategy to manage software updates throughout the product lifecycle. Ongoing, fail-safe software updates are the crux of regulatory pressures to ensure patient safety.

Reduce risk with software update best practices

Software is dynamic. With continued technological advancements, the speed of iteration and innovation has only increased. As algorithms improve, connectivity expands, and new threats emerge, manufacturers must continually manage software to stay safe, let alone move ahead of the curve.

Medical device software is updated to improve clinical outcomes, provide greater value to users, address bugs and usability issues, and reduce cybersecurity threats in an increasingly hostile digital world. Nonetheless, even minor adjustments can introduce new risks. As such, regulations from the US FDA and the EU MDR require formal procedures to evaluate each software update.

Essential factors to consider include:

• Does the update alter how the device is used or perceived?
• Could the update introduce new safety or security risks?
• Will the update require revalidation or recertification?
• Should regulators or customers be proactively informed about the update?

Ultimately, each software update is a moment of truth in which innovation must align with accountability. Getting it right protects patients, ensures compliance, and safeguards the long-term success of a connected medical product.

Ensuring software update compliance

Both the FDA and MDR consider software a component of a medical device and subject to regulation.

In the US, the FDA’s regulatory framework relies on 21 CFR Part 820, the Quality System Regulation (QSR), which emphasizes design controls, risk management, and change control to ensure device safety and effectiveness. For software, the FDA provides specific guidance documents explaining when a software change might require a new 510(k) submission, outlining expectations for managing cybersecurity risks throughout the software lifecycle, and specifying the documentation required for premarket submissions, including safety and performance justifications.

The EU MDR 2017/745 sets regulatory standards for medical device software. Software is governed independently under Rule 11 (Annex VIII), with its risk classification based on its intended use and impact. Software updates are strategic events; they can change the Basic Unique Device Identifier (UDI), shift the risk class, or necessitate renewed Notified Body involvement. Regulatory compliance is an ongoing, continuous activity, and each change must be reflected in Technical Documentation (Annexes II and III), PMS plans, and periodic safety update reports (PSURs).

To stay compliant with the MDR, manufacturers must ensure end-to-end traceability throughout the software lifecycle, proactive risk management in accordance with ISO 14971, and secure update mechanisms aligned with IEC 81001-5-1. Essentially, the MDR treats software as a standalone medical product, demanding the same rigor, traceability, and regulatory vigilance as hardware.

In a regulated medical environment, updating software involves additional layers of complexity opposed to simply deploying new code. Each software update can trigger a complex web of regulatory, technical, and quality assurance requirements.

• Complex change control means all updates require impact analysis, traceability, and revalidation.
• Risk management requires continual adherence to ISO 14971 with every significant change.
• Cybersecurity makes threat models, secure update protocols, and patch transparency mandatory.
• Documentation applies to everything from software architecture to test results, defining traceable and auditable records.
• Regulatory notification is required via a 510(k) submission for the FDA, or Regulatory Body notification for the MDR when registering a new product to market, sometimes causing delays.
• Toolchain integration ensures consistency between requirements management, version control, quality systems, and build pipelines.

Achieving compliance throughout the entire product lifecycle

A connected digital journey is essential for ensuring end-to-end traceability and audit readiness in the regulated medical device sector. Each technical element plays a specific role in supporting compliance and streamlining documentation workflows.

An integrated device management system must enable bidirectional traceability from requirements and risks to implementation, verification, and release. It must support automated audit reporting to streamline inspection readiness and regulatory submissions. It should provide continuous compliance monitoring to enable proactive detection of process deviations or gaps.

To guarantee software updates are both practical and compliant with regulatory standards, manufacturers should follow established best practices. Software updates are essential for maintaining optimal performance, ensuring security, and safeguarding patient safety. To achieve regulatory compliance, proper design controls, thorough documentation, and a solid grasp of risk management are baseline requirements for regulatory approval.

By implementing a well-organized software management lifecycle, utilizing modern solutions, and embracing cross-functional processes, manufacturers can sustain both agility and compliance. Planning for software management and compliance from the start helps medical device manufacturers establish authenticated device trust, facilitate regulatory approvals, and create safer, innovative healthcare tech.

Check out our comprehensive regulatory overview for detailed analysis and actionable best practices to help you navigate FDA and MDR compliance with confidence.

Read the overview