In Vitro Diagnostics (IVD) and Medical Device Lifecycle Management

Medical device lifecycle management is the continuous process of planning, documenting, evaluating, and updating clinical, performance, and safety evidence from development through post-market phases. It ensures devices remain safe, effective, and compliant with evolving regulatory requirements by integrating real-world data, risk assessments, and technical documentation throughout the entire product lifecycle.

CER and PER updates ensure that new clinical data, scientific literature, PMS findings, and emerging risks are accurately reflected in a device’s evidence base. Regular revision helps maintain an up-to-date benefit-risk profile, supports regulatory expectations under MDR/IVDR, and aligns documentation with real-world device performance and patient outcomes.

Post-Market Surveillance (PMS) provides ongoing evaluation of safety and performance using real-world evidence. It identifies emerging trends, usability concerns, and changes in clinical outcomes. Insights from PMS reports, PSURs, PMCF activities, and risk management updates, ensure ongoing regulatory compliance and support evidence-based decisions throughout the device lifecycle.

A Periodic Safety Update Report (PSUR) consolidates global PMS data to assess a device’s ongoing safety and performance. It evaluates emerging safety signals, benefit-risk profile, and real-world experience. Required under EU MDR, PSURs enable transparent regulatory oversight and ensure that updated evidence supports continued market authorization and patient safety.

Post-Market Clinical Follow-up (PMCF) collects ongoing clinical evidence for medical devices, whereas Post-Market Performance Follow-up (PMPF) monitors the real-world performance of IVDs. Both activities address residual risks, verify long-term performance, and strengthen the evidence supporting CERs, PERs, and safety reports. They ensure that lifecycle documentation remains aligned with current scientific and clinical knowledge in compliance with MDR/IVDR.

SSP (Summary of Safety and Performance) or SSCP (Summary of Safety and Clinical Performance) reports are regulatory documents required under MDR/IVDR that provide transparent, publicly accessible information on a device’s safety, performance, and clinical evidence. SSP is used for high-risk medical devices (Class III and implantable), while SSCP applies to higher-risk IVDs (Class C and D). Both reports consolidate data from CERs, PERs, PMS/PMCF activities, and risk assessments, ensuring clinicians, patients, and regulators have a clear overview of the device’s benefit-risk profile.

MDR/IVDR significantly impacts lifecycle documentation by increases expectations for continuous clinical evidence, rigorous evaluation, and frequent updates. Manufacturers must ensure that CERs, PERs, PMSRs, PMCF outputs, and PSURs are consistently aligned and up to date. The regulations emphasize traceability, scientific validity, and comprehensive assessments, shifting the focus from one-time submissions to ongoing, lifecycle-long evidence generation.

Medical writing in the lifecycle management of medical devices and IVDs is the structured process of creating clear, accurate, and regulatory-compliant documentation that captures clinical, scientific, and performance data, supporting compliance, safety, and ongoing evaluation of the device throughout its entire lifecycle.

Consistent documentation ensures alignment between clinical evidence, risk management files, PMS outputs, and regulatory submissions. It minimizes discrepancies, strengthens audit readiness, and supports accurate benefit-risk evaluations. Harmonized documents also streamline lifecycle updates, reducing delays and enabling clear, defensible evidence across CERs, PERs, PSURs, and technical files.

Freyr is regarded as a leading partner due to its deep understanding of evolving MDR/IVDR expectations, multidisciplinary scientific expertise, and structured approach to evidence development. Its knowledge-driven methodologies support robust clinical, performance, and post-market documentation, enabling manufacturers to maintain continuous compliance and navigate complex lifecycle requirements with clarity and confidence.