Why is traceability in medical devices crucial to your success?

In the highly regulated world of medical software development, traceability is far more than a compliance checkbox – it’s a powerful framework that ensures quality and safety across the product lifecycle. But what does true end-to-end traceability in medical devices look like in practice?

What is traceability in medical devices?

Traceability in medical devices is the structured ability to link every requirement, design decision, code change, test case, and validation activity throughout a software system’s development. For medical device manufacturers, it plays a pivotal role in achieving both regulatory compliance and operational excellence.

Traceability is the connective tissue of medical software projects. It transforms documentation into a living system that supports decision-making, risk mitigation, and audit readiness throughout the product lifecycle. By linking user needs, design decisions, implementation artefacts, and validation outcomes, it provides a comprehensive narrative of why each part of the product exists and how it evolves.

Importantly, traceability does not end with the development or release of the product. It remains critical throughout the post-market phase, supporting activities such as post-market surveillance, incident analysis, software updates, and regulatory inspections. The ability to trace back to original requirements and risk assessments becomes essential for evaluating the impact of field data and ensuring that the product continues to meet safety and performance expectations.

Traceability – aligning with regulatory frameworks

Virtually all international and regional medical device regulations and standards emphasise traceability as a foundational element of software assurance, safety, and effectiveness. Implementing a traceability strategy helps organisations streamline audits, ensure long-term maintainability, and deliver safe, compliant products to market.

Traceability in medical devices vs MDR and IVDR

Both the Medical Device Regulation (EU 2017/745) and the In Vitro Diagnostic Regulation (EU 2017/746) emphasise the importance of traceability from initial design and development, through manufacturing and market placement, to post-market surveillance.

This requirement is clearly articulated from the outset in Recital 4 of both regulations, which stress the need for transparency and the ability to trace medical and in vitro diagnostic devices as essential pillars of patient safety and regulatory control.

Traceability in medical devices is fundamental to demonstrating compliance with the General Safety and Performance Requirements (GSPRs) as outlined in Annex I of both MDR and IVDR. It plays a central role in notified body assessments and must be fully documented in the Technical Documentation (Annex II), as well as in the Clinical Evaluation Report (CER) for MDs or the Performance Evaluation Report (PER) for IVDs. This includes linking intended use, design specifications, risk control measures, verification and validation activities, and real-world evidence gathered after market launch.

Under the MDR, traceability is a critical requirement for all medical devices. Notified bodies pay particular attention to the transparency of design decisions and the effectiveness of risk mitigation measures, including cybersecurity risks and software updates, which is especially important for software classified as a medical device under Rule 11. 

Similarly, under the IVDR, software that qualifies as a standalone IVD or is embedded within an IVD must demonstrate full traceability between performance claims, risk controls, and data supporting clinical performance and scientific validity.

Beyond design and development, both regulations extend traceability obligations to include identifiability across the supply chain, supported by systems such as the Unique Device Identification (UDI) mechanism. These requirements ensure that devices can be reliably tracked throughout distribution and post-market phases, enabling effective vigilance, corrective actions, and recall procedures when necessary.

In short, traceability under MDR and IVDR is a systemic requirement that underpins product quality, regulatory compliance, and, most importantly, protects patient safety.

FDA Guidance on Software as a Medical Device (SaMD)

For SaMD, the FDA recommends rigorous traceability to support clinical evaluation, cybersecurity risk mitigation, and life cycle documentation, aligned with guidance from the International Medical Device Regulators Forum (IMDRF). This includes clear trace links between software claims, intended use, performance requirements, and testing outcomes.

FDA 21 CFR Part 820 – Quality System Regulation (QSR)

The FDA’s Quality System Regulation (QSR, 21 CFR Part 820) requires manufacturers to establish and maintain procedures for design control, including traceability from design input through to verification and validation. However, traceability extends beyond the design phase. It is a fundamental part of the entire quality management system (QMS), supporting activities such as change control, complaint handling, and post-market risk management.

Specific requirements related to identification and traceability are defined in Subpart F of 21 CFR Part 820. Notably, §820.60 mandates procedures to ensure product identification throughout all stages of receipt, production, and distribution in order to prevent mix-ups. In addition, 21 CFR Part 821 (Medical Device Tracking Requirements) imposes obligations for post-market traceability of certain devices, further reinforcing the need for robust traceability systems across the entire product lifecycle.

The FDA expects to see clear traceability matrices and documented justification for all risk mitigations, particularly for Class II and III devices. Well-established traceability also supports the FDA’s Premarket Notification (510(k)) and Premarket Approval (PMA) processes, enabling efficient review of how design decisions relate to intended use, clinical performance, and safety controls throughout the product’s lifecycle.

ISO 13485 – Quality Management Systems for Medical Devices

This standard establishes the requirements for a QMS specific to medical device development. ISO 13485 requires documented traceability of design inputs, design outputs, and verification activities.

In fact, traceability is specifically addressed in the entire Clause 7.5.9, emphasising its importance. It ensures that each requirement can be traced from concept to release, including alignment with regulatory expectations, thereby strengthening internal audits and readiness for external inspections.

ISO 14971 – Application of Risk Management to Medical Devices

Although focused on risk, ISO 14971 interlocks with traceability by requiring that risk control measures will be traceable from hazard identification to implementation and verification. Maintaining trace links between identified risks, control measures, and verification evidence is crucial to demonstrating a closed-loop risk management process.

IEC 62304 – Medical Device Software Lifecycle Processes

IEC 62304 provides a framework for the safe design and maintenance of medical software. It mandates risk-based software classification and requires traceability between software system requirements, architectural design, detailed design, implementation, verification, and problem resolution. 

Importantly, the standard explicitly defines traceability in medical devices as the degree to which relationships can be established between development process deliverables, ensuring this traceability is maintained throughout the lifecycle to support risk management and software safety.

IEC 82304-1 – Health Software Safety

This standard addresses the entire lifecycle of health software, emphasising safety and security aspects. It includes requirements for traceability to help ensure safety requirements are clearly specified and validated across the system architecture and test plans. This is particularly relevant for standalone software or mobile health applications.

Strategic benefits of traceability in medical devices

Beyond meeting regulatory demands, traceability can unlock significant strategic value. When managed well, it supports the team developing medical software through the whole process.

Decision transparency

Trace links provide a forensic-level view into the rationale behind key architectural or functional decisions. Whether evaluating an old feature for upgrade or defending a design choice during an audit, traceability ensures that the original context (including risk considerations, clinical input, and regulatory constraints) is always accessible. This promotes consistency, accountability, and long-term maintainability.

Team alignment across functions

Traceability acts as a common language between development, QA, regulatory affairs, product management, and clinical teams. It minimises miscommunication by ensuring that every stakeholder works from a shared understanding of product requirements, risk controls, and regulatory obligations. 

Change impact analysis

In complex medical products, even small requirement changes can trigger ripple effects. Traceability enables rapid and accurate impact assessments by showing which subsystems, code modules, or tests are affected. This significantly reduces the risk of unintended consequences and ensures the safe, controlled evolution of the product.

Acceleration of regulatory readiness

With traceability embedded from the start, the burden of assembling regulatory documentation is drastically reduced. Teams can generate trace matrices on demand. This not only accelerates submission timelines but also reduces stress and effort during regulatory inspections.

Support for iterative development and continuous improvement

Traceability provides feedback loops that drive data-informed improvements. For example, recurring test failures linked to certain requirements may indicate design flaws or usability issues. By tracing post-market data and, where applicable, Corrective and Preventive Action activities (CAPA) back into development inputs, traceability supports a closed-loop quality system that thrives on learning.

Business resilience and knowledge retention

In environments with team turnover, acquisitions, or expanding product portfolios, traceability ensures that critical product knowledge is preserved, not trapped in tribal memory. New team members or external stakeholders can quickly ramp up with confidence by following the documented trail of how the product was built, tested, and released.

Strategic asset for Product Lifecycle Management (PLM)

Traceability aligns perfectly with modern PLM strategies, enabling data reuse across versions, product families, and markets. It supports portfolio-level visibility, allowing executives to evaluate risk exposure, test coverage, or market-specific compliance at a glance.

Turning traceability into an asset

Traceability in medical devices is more than a regulatory obligation – it is a unifying framework that safeguards patients, strengthens development practices, and accelerates innovation. By embedding it across the lifecycle of medical software, organisations meet the requirements of the regulatory norms. That’s why when looking for a company to support you in medical software development, we encourage you to look for a team who take traceability to heart.