Clinical Evaluation and Labelling: How They Are Interlinked

Multiple guidance documents issued by the Medical Device Coordination Group (MDCG) provide detailed insights into this interdependence:

• MDCG 2020–13 emphasizes the importance of taking all necessary steps to ensure that medical devices are safe, effective, and compliant with regulatory requirements.
• MDCG 2021–24 explains how data on safety and performance arising from clinical evaluation directly affect the labeling elements, including the IFU, warnings, and contraindications.
• MDCG 2020–6 emphasizes that labeling should be based on clinical data, so that the label accurately reflects the intended purpose of the device, target population, safety, and performance.

Together, these guidances highlight the critical connection between clinical evaluation and labeling. Clinical evaluations provide evidence-based data that shape key labeling elements to ensure the following:

1. Compliance with GSPRs: Both clinical evaluation and labeling comply with the regulatory requirements set in MDR Annex I, thereby ensuring that the device is safe and performs well.
2. Minimized Risks: Evidence-based and fact-based labeling derived from clinical data helps minimize risks associated with the usage of a device by effectively communicating warnings, contraindications, and proper usage instructions.
3. Support for Intended Use: The intended purpose, target population, and usage instructions of the device are clearly articulated in the labeling, supported by robust clinical evaluation data.

The Interlink: How Clinical Evaluation and Labelling Work Together

The relationship between clinical evaluation and labeling is that both have, as a common goal, the safe use of medical devices in ensuring effective use.

Clinical evaluation provides evidence for the safety, performance, and use of a device, while labeling converts evidence into actionable, user-friendly information.

The interplay of these two processes ensures real-world application of the device in alignment with data generated when it was evaluated.

1. Feedback Loop for Continuous Improvement

Clinical evaluation and labelling form a dynamic feedback loop. Post-market clinical follow-up (PMCF) and vigilance activities continuously generate new clinical data, which may highlight emerging risks, novel use cases, or updates to the device’s performance profile.

This updated information feeds back into labelling, ensuring it remains current and reflects the latest clinical findings.

2. Customization for Stakeholders

The clinical evaluation supports the customization of labelling to meet the needs of diverse user groups, including healthcare professionals, lay users, and patients.

For instance, while healthcare professionals may require detailed scientific explanations, lay users benefit from simplified language and visual instructions. This tailored approach ensures that all users can understand and apply the device information effectively.

3. Mitigating Use Errors

The labelling process draws heavily on the outcomes of clinical evaluation to address potential use-related risks identified during clinical investigations or usability studies. By incorporating these insights, manufacturers can refine their Instructions for Use (IFU) and warnings to reduce errors, enhance user comprehension, and improve device handling across all intended settings.

4. Evidence-Based Marketing Claims

Clinical evaluation data not only confirm safety and performance but also serve as the basis for marketing claims. Elements of labelling, including promotional materials or brochures, must be in line with the evidence provided in the Clinical Evaluation Report (CER).

This will ensure that all claims are substantiated, avoiding misleading information and creating trust among users.

5. Facilitating Regulatory Compliance

Regulatory bodies assess the coherence between clinical evaluation and labelling as part of their conformity assessment process. Discrepancies between the two can result in regulatory delays or rejection.

The integration of clinical data into labelling ensures that both processes support each other in demonstrating compliance with the MDR, ultimately expediting approvals and market access.

This interdependency between clinical evaluation and labelling ensures that the device not only meets regulatory requirements but also delivers optimal performance and user satisfaction throughout its lifecycle.

By maintaining this synergy, manufacturers can achieve a balance between scientific rigor and practical usability.

Interlinking Factors:

· Risk Information: Clinical evaluation identifies risks associated with the device. These risks must be clearly outlined in the labeling, with corresponding instructions for risk mitigation.

· Indications for Use: The clinical evaluation helps define the intended use and patient population for the device. The labeling must accurately reflect this, detailing indications, patient criteria, and any restrictions.

· Performance and Safety Data: This would provide clinical data on how well the device functions and whether it is safe, critical for accurate labeling. All such new information-whether in post-market surveillance data or adverse event reports-may call for the updating of the labeling.

· Post-Market Surveillance: After a device is released into the market, post-market clinical evaluation through data can make changes in the labeling to include revised contraindications or updated usage instructions.

Conclusion

Synergies between the clinical evaluation and labeling assure the medical devices under the MDR 2017/745 are safe, perform appropriately, and maintain regulatory requirements.

Manufacturers, thereby, combine the integration of evidence-based data within user-centric labeling to gain regulatory compliance along with enhancing stakeholder’s trust and confidence.

Aligning for optimal device communication would be central to continuous progress in these areas: improvements in usability, risk reduction, and market acceptance. This interplay allows manufacturers to navigate the intricacies of regulatory frame works while providing the best possible medical devices with regard to safety and efficacy.

Author Name : Athira Unnikrishnan

Author designation: Junior Consultant (CER)

References

1. The EU MDR outlines the requirements for clinical evaluation and labelling. Key sections include:

2. MDCG 2020–13: Clinical Evaluation Assessment Report Template.

3. MDCG 2021–24: Guidance on Label and Instructions for Use.

4. MDCG 2020–6: Clinical Evidence Needed for Devices.