Clinical Evaluation and Risk Management Under MDR – Best Practices for Rollators

For manufacturers of Class I medical devices such as rollator walkers, meeting the clinical evaluation and risk management requirements of MDR (EU) 2017/745 is critical. This article outlines how brands like RELAXSMITH ROLLATOR comply with Annex XIV and ISO 14971 to ensure user safety and regulatory acceptance.

1. The Importance of Clinical Evaluation for Class I Devices

• Not Optional: Clinical evaluation is required for all devices, including Class I, and must be updated throughout the product lifecycle.
• Objective: To demonstrate conformity with relevant General Safety and Performance Requirements (GSPRs).
• Data Sources: Literature review, existing clinical studies, or equivalence data are acceptable—but must be justified and documented.

2. The RELAXSMITH ROLLATOR Approach to Clinical Evaluation

• Equivalence Method: RELAXSMITH ROLLATOR compares its product to CE-certified European models with similar materials and use cases.
• User Trials: Real-world feedback from elderly users in Germany and the Netherlands feeds into performance summaries.
• CER Updates: The Clinical Evaluation Report is updated every 12 months or upon major design changes.

3. Risk Management with ISO 14971

• Hazard Identification: Covers frame fracture, brake failure, instability on slopes, ergonomic strain.
• Risk Estimation: Probability x severity matrix applied to every identified hazard.
• Risk Control Measures: Design mitigations, labeling warnings, and service instructions reduce residual risks.

4. Integration into the Technical File

• Cross-Linking: Clinical and risk sections reference corresponding GSPRs, BOM, and labeling documentation.
• Reviewer Ready: RELAXSMITH ROLLATOR organizes CER and RMF into standalone, indexed binders for notified body review.
• Audit Trail: Version-controlled updates ensure traceability of every revision.

5. Key Takeaways

• Document your equivalence justification clearly and include technical specs of the compared device.
• Use ISO 14971 framework consistently and link it to actual user feedback or PMS data.
• Update CER annually and whenever product changes occur, even for Class I devices.