productdif.com The Clinical Evaluation Report (CER) synthesizes existing clinical data and literature to demonstrate a medical device's safety and performance, while a Clinical Investigation involves the collection of new clinical data through planned studies. A CER is essential for regulatory submissions and post-market surveillance, providing a comprehensive analysis of device performance based on previous evidence. In contrast, Clinical Investigations are conducted when existing data is insufficient, ensuring direct assessment of the device in real-world or controlled settings.
Table of Comparison
| Aspect | Clinical Evaluation Report (CER) | Clinical Investigation (CI) |
|---|---|---|
| Purpose | Assessment of existing clinical data to demonstrate device safety and performance | Generation of new clinical data through a prospective study |
| Regulatory Requirement | Mandatory for CE marking under EU Medical Device Regulation (MDR) | Required when existing data are insufficient for device evaluation |
| Data Source | Published literature, clinical studies, post-market surveillance | Controlled clinical trials or observational studies with device users |
| Duration | Typically shorter; based on review of existing evidence | Longer; involves patient recruitment and follow-up |
| Outcome | Comprehensive report supporting device safety, performance, and benefit-risk profile | Primary clinical data providing direct evidence of device safety and effectiveness |
| Application | Essential for device conformity assessment and market authorization | Supports CER or regulatory submissions when evidence gaps exist |
Introduction to Clinical Evaluation Report (CER) and Clinical Investigation
A Clinical Evaluation Report (CER) compiles existing clinical data to assess the safety and performance of a medical device, confirming compliance with regulatory standards such as the MDR 2017/745. In contrast, a Clinical Investigation involves the prospective collection of new clinical data through structured studies or trials, targeting specific clinical claims or device improvements. Both processes are crucial for regulatory approval but serve different roles in demonstrating a device's clinical safety and efficacy.
Definitions: CER vs Clinical Investigation
A Clinical Evaluation Report (CER) systematically compiles and assesses clinical data from existing sources to demonstrate a medical device's safety and performance. In contrast, a Clinical Investigation involves conducting prospective, structured clinical trials directly with patients to gather new clinical evidence. CERs utilize literature reviews and post-market data, whereas Clinical Investigations generate original clinical data under controlled study conditions.
Purpose and Objectives of CER
The Clinical Evaluation Report (CER) aims to systematically assess clinical data to verify the safety and performance of a medical device in accordance with regulatory requirements like MDR 2017/745. Its primary objectives include synthesizing existing clinical evidence, identifying potential risks, and demonstrating conformity with clinical benefits. Unlike a Clinical Investigation, the CER does not involve new clinical trials but relies on comprehensive data analysis to support market approval and post-market surveillance.
Purpose and Objectives of Clinical Investigation
Clinical Investigation aims to generate primary clinical data to verify the safety and performance of a medical device under real-world conditions. Its objectives include assessing device functionality, identifying potential risks, and gathering evidence to support regulatory submissions. In contrast, the Clinical Evaluation Report synthesizes existing clinical data to demonstrate compliance with safety and performance requirements.
Regulatory Requirements: CER and Clinical Investigation
The Clinical Evaluation Report (CER) is a mandatory document under MDR 2017/745, summarizing clinical data to demonstrate device safety and performance, while a Clinical Investigation involves systematic gathering of clinical data through trials to generate new evidence. Regulatory requirements for CER focus on continuous assessment of existing clinical evidence to support device conformity, whereas Clinical Investigations require formal approval from notified bodies and ethics committees before initiation. Both processes ensure alignment with ISO 14155 standards for good clinical practice and must be thoroughly documented for regulatory submissions.
When to Conduct CER versus Clinical Investigation
A Clinical Evaluation Report (CER) is conducted when existing clinical data sufficiently demonstrate a medical device's safety and performance, typically during pre-market approval or post-market surveillance processes. A Clinical Investigation is necessary if there is insufficient clinical evidence or significant changes to the device that require new data to assess safety and effectiveness. Regulatory frameworks like MDR 2017/745 emphasize CER for continuous evaluation, while Clinical Investigations are mandated for novel devices or substantial modifications lacking adequate clinical data.
Methodologies: Literature Review vs Clinical Trials
Clinical Evaluation Reports (CERs) primarily use literature review methodologies, systematically analyzing existing clinical data and scientific literature to assess a medical device's safety and performance. Clinical Investigations involve prospective clinical trials, collecting new, specific patient data through controlled environments to directly evaluate device efficacy and risks. The thoroughness of literature review in CERs contrasts with the empirical, real-world evidence generated by clinical trials in Clinical Investigations.
Data Sources for CER and Clinical Investigation
Clinical Evaluation Reports (CER) primarily rely on data sources such as published clinical literature, clinical experience, and post-market surveillance data to evaluate the safety and performance of a medical device. Clinical Investigations collect primary data through prospective, systematic studies involving human subjects designed to generate direct evidence on device performance. The distinction in data sources is crucial since CERs synthesize existing information while Clinical Investigations produce new clinical data under controlled conditions.
Key Differences between CER and Clinical Investigation
The Clinical Evaluation Report (CER) systematically reviews existing clinical data to demonstrate the safety and performance of a medical device, whereas Clinical Investigation involves the collection of new clinical data through controlled studies or trials. CER relies on comprehensive literature analysis, post-market surveillance, and previous investigations, serving as a continuous process to validate device compliance with regulatory requirements such as MDR 2017/745. Clinical Investigation, contrasted by its empirical approach, is essential for investigational devices or new device indications, providing primary evidence through patient involvement and monitored clinical endpoints.
Implications for Medical Device Regulatory Approval
The Clinical Evaluation Report (CER) compiles existing clinical data to demonstrate a medical device's safety and performance, serving as a critical document for regulatory submissions and CE marking under MDR 2017/745. Clinical Investigation involves prospective studies on human subjects to generate new clinical evidence, often required when existing data are insufficient for regulatory approval. Regulatory authorities rely on the robustness of CERs for devices with established histories, while novel or high-risk devices necessitate clinical investigations to meet stringent approval criteria and ensure patient safety.
Clinical Evaluation Report vs Clinical Investigation Infographic
