Clinical Evaluation Report Updates (CER Updates)
The Clinical Evaluation Report (CER) holds a central role in the compilation of essential technical documentation required to attain a CE marking, allowing a medical device to be manufactured and distributed within the European Union (EU). The primary objective of creating a CER is to uphold patient safety and ensure the optimal performance of the device, making it imperative to regularly revise and update this document. The frequency of Clinical Evaluation Report / CER Updates is contingent upon various factors, including the device’s risk classification, the most recent research findings, and post-market surveillance activities, among other crucial considerations.
Over the course of the device life cycle, the Clinical Evaluation Report should be regularly updated for evaluating device’s performance and safety. This is an essential part of making sure a medical device stays safe and functional for the purpose for which it was designed. Updates should be made if the manufacturer finds out any PMS or PMCF data that could affect the current evaluation or its conclusions
When to Update a Clinical Evaluation Report (CER Update)
The process of preparing and submitting the initial report marks just the commencement of the Clinical Evaluation Report (CER) life cycle. Guidlines necessitates regular updates to ensure its continued relevance and accuracy. CER updates are mandated on an annual basis, triggered when the manufacturer receives new information from post-market surveillance that could potentially alter the existing evaluation. Alternatively, updates may be required every two to five years for well-established medical devices with minimal user and patient risks, contingent on the device’s risk classification.
Section 6.2.3 of MEDDEV 2.7/1 revision 4 provides manufacturers with guidance on determining the frequency of CER updates. It underscores the manufacturer’s responsibility to define and justify the update frequency based on several factors, including the medical device’s invasiveness, complexity, design, risk classification, target population risks, adverse event reporting ratios, and the inclusion of the latest clinical research data, among others.
Using these metrics and a systematic approach, manufacturers must establish the appropriate CER update frequency for each specific device.
However, irrespective of the proposed rationale for the update frequency, manufacturers are obligated to update the CER when new information emerges from post-market surveillance activities that could alter the current clinical evaluation. This may include safety reports, recently published literature, or Post-Market Clinical Follow-Up (PMCF) studies that reveal previously unknown safety concerns. Continuous evaluation of clinical data from these sources is essential, as it can potentially impact the device’s risk-benefit profile. If new clinical data indicates a change in the risk-benefit profile, compromises the safety or performance of the device, or refutes any claims associated with the device, the manufacturer must promptly update the CER and consider further necessary actions.
Major Clinical Evaluation Report Updates
The following are the main components to be considered for clinical evaluation updates:
- Post-Market Surveillance (PMS): PMS is the periodic collection and analysis of data pertaining to the device’s performance once it is on the market. It mainly includes user feedback updates, monitoring adverse events or complaints, and any emerging performance or safety concerns.
- Adverse Event Reports and Complaints: It is critical to track and assess user complaints and adverse events. The manufacturers should have a reliable system for gathering and analysing the collected data.
- Response from users and Health professionals: Reports and feedback from the healthcare professionals and users are very important. Any responses with respect to the device’s performance, usability and safety should be considered and recorded.
- Clinical Analysis and Studies: It is necessary to evaluate the safety and efficacy of the device, if any new data or clinical evidence becomes available.
- Scientific Literatures: It is very important to review scientific literature regularly to identify any new research or findings related to the device or similar devices.
- Regulatory Requirements: Regulatory concerns may vary over time. The manufacturers need to make sure that their medical device continue to comply with evolving standards.
- Labelling and Usage Instruction: It is very essential to update the label and instructions for use, considering any new modifications to the intended use.
- Reevaluating the device’s risk profile based on real-world data and clinical evidence.
- Risk-Benefit Analysis: Periodic risk-benefit analysis is necessary to evaluate if the device’s benefits outweigh its risks.
- Clinical Evaluation Report Update: New information and data related to the clinical performance and safety of the device should be updated in the clinical evaluation report (CER).
- Corrective and Preventive Actions, or CAPA: Manufacturers are required to take corrective and preventive action to resolve issues or concerns that are identified.
- Periodic Safety Update Reports (PSUR): Manufacturers may need to submit PSURs regularly summarising the safety and clinical performance of the device, depending on the class and risks associated with the device.
- Communication with the Competent Authorities: Manufacturers may be required to communicate with the notified bodies regularly to report on the safety and performance of the device.
Clinical Evaluation is an ongoing process, requiring manufacturers to have a systematic approach for data collection, analysis, and action to ensure safety, effectiveness, regulatory compliance, and device quality throughout their life cycle. This procedure is essential for complying with the regulatory requirements and maintaining the safety and efficacy of the medical device throughout its life cycle.