At EPINTEK, we understand the complexities involved in preparing a Clinical Evaluation Report (CER) under the stringent requirements of the European Union Medical Device Regulation (EU MDR). Our comprehensive services guide you through each of the five critical stages to ensure your medical devices meet all necessary compliance standards. Here’s how we can assist you:

Stage 0: Detailed Device Description

The first step involves creating an exhaustive description of your medical device as per MEDDEV 2.7/1 rev.4 Appendix A3. This includes:

ü Device Identification: Model numbers, sizes, software versions, accessories, and components.

ü Physical and Chemical Descriptions: Materials used, any incorporated drugs or blood products, mechanical and physicochemical characteristics.

ü Technology Used: Innovative aspects of the device's development.

ü Therapeutic/Management/Diagnostic Applications: Exact intended use and medical indications.

Stage 1: Identifying Relevant Data

In this stage, we help identify both direct and indirect clinical data pertinent to your device:

ü Direct Clinical Data: Includes preclinical test reports, validation and confirmation data, pre-market clinical trials, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) data generated by the manufacturer.

ü Indirect Clinical Data: Involves identifying equivalent devices with the same intended purpose and discussing their clinical, technical, and biological characteristics.

Stage 2: Assessing Relevant Data

Our team evaluates the relevance and scientific validity of the identified data, ensuring its contribution to demonstrating conformity:

ü Methodological Quality: Assessing the quality and scientific validity of methodologies used.

ü Relevance Determination: Identifying how relevant each dataset is to the clinical evaluation.

ü Weight Contribution: Assigning weight to each piece of data based on its impact on the overall assessment.

Stage 3: Analyzing Clinical Data for the Medical Device

This phase involves analyzing the data to draw conclusions about the device’s performance and safety:

ü Performance and Safety: Ensuring compliance with essential requirements, including benefit-risk ratios.

ü Technical Documentation: Reviewing positive aspects of the device’s technical file.

ü Risk Management: Addressing residual risks, uncertainties, complications, long-term performance, and real-world safety considerations.

ü Post-Market Data: Including PMS data for CE-marked devices already on the market.

Stage 4: Finalizing the Report

The final stage involves compiling all the information gathered and analyzed into a comprehensive CER:

ü Compilation: Summarizing all stages of the clinical evaluation process.

ü Approval and Data Validation: Ensuring all data is approved and validated.

ü CVs and Declarations of Interest: Including resumes and declarations of interest for transparency.

By partnering with EPINTEK, you gain access to expert guidance at every stage of the CER preparation process under EU MDR. We ensure that your clinical evaluation is thorough, compliant, and ready for submission, helping you bring safe and effective medical devices to market efficiently. Let us be your trusted advisor in navigating the complexities of EU MDR compliance.

For more information about our services or to tailor specific solutions, please contact our professional team.