MedTech Writing and Consulting

Clincial Evaluation Plan

Clinical Evaluation Report

Clinical Evaluation Plans (CEPs)

A Clinical Evaluation Plan (CEP) is a critical component of the regulatory requirements for medical devices, especially under the EU MDR. It outlines the strategy and methodology that a manufacturer will use to assess the clinical performance and safety of a device throughout its lifecycle. The CEP serves as the foundation for the Clinical Evaluation Report (CER), detailing the clinical data that will be collected and analyzed to demonstrate that the device meets essential performance and safety requirements.

The CEP must be comprehensive, covering the device's intended purpose, risk class, and specific characteristics. It should describe the criteria for literature reviews, the process for collecting clinical data (including data from PMS activities), and the methods for analyzing this data to ensure ongoing compliance with regulatory standards. This plan also needs to address how new data from PMS, such as adverse events, literature updates, and other relevant findings, will be integrated into the clinical evaluation process to continuously update and refine the benefit-risk profile of the device.

By having a robust CEP, manufacturers can ensure that their clinical evaluations are methodically planned, evidence-based, and aligned with regulatory expectations, thereby facilitating smoother regulatory submissions and ongoing market access.

Clinical Evaluation Report

A Clinical Evaluation Report (CER) is a comprehensive document that presents the findings of a clinical evaluation for a medical device, as required under the EU MDR. The CER is pivotal in demonstrating that a device is safe and effective for its intended use, providing evidence that it meets the necessary regulatory standards throughout its lifecycle. This report consolidates and analyzes clinical data gathered from various sources, including clinical studies, scientific literature, post-market surveillance (PMS) data, and real-world use.

The CER is built upon the foundation laid by the Clinical Evaluation Plan (CEP), following the methodology and criteria outlined in the plan. It systematically assesses the device's performance, safety, and benefit-risk profile by analyzing both pre-market and post-market clinical data. The report must also identify any gaps in the clinical evidence and outline how these will be addressed. Moreover, the CER should integrate new data from ongoing PMS activities, such as adverse event reports, literature reviews, and other relevant findings, to ensure the device remains compliant with regulatory requirements over time.

A well-prepared CER is essential for maintaining market access and regulatory compliance. It supports the manufacturer's claims about the device's safety and efficacy, helps in risk management, and is a critical component of the technical documentation required for regulatory submissions and audits.

When do I need to write a CER?

What other triggers are there for CERs?

Several key events in the lifecycle of a medical device trigger a Clinical Evaluation Report (CER). One of the primary triggers is the initial regulatory submission, where a CER is required to demonstrate that a new device meets safety and performance standards before it can be marketed.

Additionally, a CER must be updated periodically to ensure that the device continues to comply with regulatory requirements, particularly in response to new data gathered from post-market surveillance (PMS) activities, such as adverse event reports, new clinical studies, or significant changes in the device's intended use or design.

Class III and implantable device CERs need to be updated annually, whereas the other risk classes can be updated anywhere from 2-5 years from the initial CER, depending on how novel and the risk level of the technology. We advise CERs to be updated every 2 years for Class IIb products, and every 3 years for Class IIa and Class I products, to show Regulatory Bodies that you (as a manufacturer) are responsibly maintaining your documents.

What other triggers are there for CERs?

Other triggers for updating a CER occur when there is a significant regulatory or market-driven change, such as an update to the EU MDR. Additionally, when new safety or performance issues arise, or there is a change to the benefit-risk profile, either from internal data or external sources, a CER is required to be updated.

Manufacturers are also required to revise the CER when expanding the device's market, particularly in regions with different regulatory standards, or when new literature or clinical data emerges that could impact the device's benefit-risk profile. These triggers ensure that the CER remains current and reflective of the most up-to-date clinical evidence, supporting the ongoing safety and efficacy of the device.