Welcome to MDSS, your trusted partner in ensuring the safety and compliance of medical devices. Our specialized services include crafting comprehensive Clinical Evaluation Reports (CERs), a critical component in establishing the clinical safety and performance of medical devices.
What is a Clinical Evaluation Report (CER)?
At MDSS, we redefine the CER as more than just a document—it’s a meticulous exploration of clinical data, a comprehensive journey into the performance and safety of your medical device. With our wealth of expertise, we craft a detailed CER that encapsulates all facets of clinical use and pertinent non-clinical testing data. Our commitment goes beyond regulatory requirements; we strive for excellence to ensure your CER provides a substantial benefit-risk analysis for your medical device.
What Does a Clinical Evaluation Report (CER) Include?
At MDSS, our CERs follow a proven and effective structure using the Claim, Evidence, Reasoning (CER) model. This strategic approach ensures clarity and precision in our reports. Let’s break down the components:
Claim: The Claim is the cornerstone, addressing pivotal questions about the medical device under evaluation. It serves as the focal point, clearly stating our findings and conclusions based on a thorough analysis of clinical data.
Evidence: Our reports draw extensively from diverse sources, both clinical and non-clinical. The Evidence section is a comprehensive compilation of data supporting the claim. We meticulously analyze clinical investigation results, scientific literature, post-market surveillance data, and more, ensuring a well-rounded and robust foundation.
Reasoning: To establish a solid scientific foundation, we employ the Reasoning component. This section provides a logical and systematic explanation of how the evidence supports the claim. It delves into the methodology, relevance, and scientific validity of the data, ensuring transparency and reliability.
This methodical application of the CER model ensures that every report produced by MDSS is not just a document but a comprehensive narrative. Our commitment lies in delivering CERs backed by solid scientific principles, providing you with a reliable and thorough assessment of your medical device’s safety and performance.”
How to Prepare a Comprehensive Clinical Evaluation Report (CER) for Medical Devices
Embarking on the preparation of a Clinical Evaluation Report (CER) for medical devices involves a systematic four-step process:
Step 1: Establishing the Clinical Evaluation Plan (CEP)
In the initial phase, the manufacturer lays the foundation by establishing or updating the Clinical Evaluation Plan (CEP). This involves defining the scope of the evaluation and documenting the approach that will be taken.
Step 2: Identifying Relevant Clinical Data
The second step revolves around identifying clinical data pertinent to the device under evaluation and its intended purpose. Reviewing sources such as clinical investigations, Post-Market Surveillance (PMS) data, clinical literature, and equivalence data is conducted to pinpoint any gaps in clinical evidence, placing particular emphasis on Post-Market Clinical Follow-up (PMCF).
Step 3: Appraising Clinical Data Quality and Relevance
The third phase is critical for evaluating the quality, relevance, and scientific validity of the identified clinical data. If gaps are identified, new or additional clinical data is generated to address these deficiencies. This step ensures a robust foundation for the Clinical Evaluation Report.
Step 4: Articulating Sufficient Clinical Evidence
In the final step, the manufacturer articulates that there is ample clinical evidence for each relevant General Safety and Performance Requirement (GSPR) that necessitates clinical data. This comprehensive overview demonstrates that the device meets the necessary safety and performance standards.
Elements to Include in the CER
- General Information: Device and manufacturer name.
- Device Description: A concise physical and technical description of the device, along with its intended purpose.
- Therapeutic/Diagnostic Claims: An outline of therapeutic or diagnostic claims supported by relevant data.
- Clinical Benefits and Outcome Measures: Highlighting clinical benefits and associated outcome measures.
- State of the Art: An analysis of the current state of the art, including benefits and risks of alternatives to the device under evaluation.
- Summary and Appraisal of Clinical Data: A comprehensive summary and appraisal of the gathered clinical data.
- Data Analysis for GSPR Conformity: Analysis of data to demonstrate conformity with relevant GSPRs, including performance, safety, and acceptability of benefit-risk ratio.
- Conclusions: A conclusive section summarizing key findings.
- Evaluator Qualifications: Information on the qualifications of the evaluator or evaluation team.
By adhering to these steps and incorporating the listed elements, manufacturers can ensure the preparation of a robust Clinical Evaluation Report that meets regulatory standards and provides a comprehensive assessment of their medical device.
Why Choose MDS Solutions For CER Reports?
At MDS Solutions, we provide knowledge-based expertise to assist you in crafting a comprehensive clinical strategy and plan, meticulously documenting the entire clinical evaluation process for your medical device journey—from initiation to completion.
Integrated Team Approach
Our collaborative team at MDS Solutions, consisting of regulatory affairs specialists, literature review experts, medical writers, medical advisors, and project managers, works seamlessly together to produce impactful outcomes. This integrated approach ensures a holistic perspective and accelerates the preparation of required documentation.
Efficiency in Documentation
We recognize the significance and time-sensitivity of producing accurate and well-written documentation. Our team is committed to expediting the preparation process, ensuring that your documentation meets regulatory standards and is of the highest quality.
Regulatory Compliance Assurance
With a team well-versed in regulatory affairs, we assure you that your documentation is not only efficiently prepared but also in full compliance with the latest regulatory requirements. This commitment is crucial for the successful navigation of the regulatory landscape.
Expertise Across Disciplines
Our diverse team brings expertise from various disciplines, covering regulatory affairs, literature review, medical writing, and advisory roles. This breadth of knowledge ensures a thorough and well-rounded approach to your clinical strategy and evaluation documentation.
Tailored Solutions for Your Journey
Recognizing that each medical device journey is unique, we offer tailored solutions that align with your specific needs. Suppose you’re initiating a new endeavor or aiming to improve an ongoing clinical evaluation process. In that case, our team is ready to offer tailored support to meet your specific needs.
Choose MDS Solutions as your partner for a streamlined, efficient, and expertly crafted clinical strategy and plan. Our collaborative team approach guarantees not only the acceleration of documentation preparation but also the delivery of high-quality, regulatory-compliant outcomes throughout your medical device journey.
Meeting EU Regulatory Standards
In the European Union, adherence to the Medical Devices Regulation (MDR) 2017/745 is a prerequisite for all medical devices, excluding custom-made variants. MDSS specializes in developing Technical Documentation – a critical component for securing CE marking and complying with EU regulations for medical device distribution.
Exemption and Notified Body Audits
While Class I devices enjoy the flexibility of self-certification, it’s crucial to note that all other device classes require a comprehensive Technical Documentation audit, which includes the indispensable Clinical Evaluation Report (CER) conducted by a Notified Body. This meticulous process ensures that your device not only aligns with but surpasses the rigorous standards mandated by the MDR, positioning it for successful entry into the European market.
Our MDR Compliance Expertise
MDSS stands as your trusted ally in navigating the complexities of MDR compliance. Our seasoned team of experts possesses unparalleled knowledge of the regulatory landscape, guaranteeing that your Technical Documentation, inclusive of the CER, not only fulfills but surpasses the stringent EU requirements. Opt for MDSS to ensure a smooth journey through EU regulatory processes – from meticulous documentation preparation to thorough Notified Body audits.
Get in Touch for Expert Clinical Evaluation Report (CER) Services
Ready to elevate your Clinical Evaluation Report (CER) with precision and compliance? Contact us today for top-tier CER Reporting services. Let our expert team streamline your documentation process and ensure regulatory excellence. Reach out to us now to Let’s talk about your particular requirements and start a new journey toward comprehensive and quality clinical evaluations. Your success begins with a simple click or call – contact us for unparalleled CER services.