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Clinical Evaluation

Clinical Evaluation for Medical Devices

  2. Services
  3. CE Certification Consultancy
  4. Preparation of Clinical Evaluation for Medical Device

We deal with the aspects of professional Consulting for medical devices

We are a Leading Medical Device Regulatory Consultancy, Specializing in Clinical Evaluation and Regulatory Compliance Solutions for Medical Devices and in vitro diagnostics medica device (IVDs).

Our experienced regulatory consultants team helps medical device manufacturers understand the complex regulatory requirements, ensuring their medical devices meet high-quality standards. From regulatory consultations to audits and certification, we guide medical device businesses through the process, helping them achieve quicker market entry while ensuring patient safety. We specialize in medical device clinical evaluation, clinical performance evaluation, and preparing clinical evaluation reports for medical devices, all while ensuring compliance with MDR clinical evaluation standards.

What is Clinical Evaluation?

Clinical Evaluation is a detailed process where clinical data about a medical device is reviewed to make sure it is safe, works well, and meets the necessary rules and standards. This process looks at scientific studies, clinical trials, and data after the device is on the market to ensure it works as intended and doesn’t harm patients. Clinical evaluation is an important step in making informed decisions and is needed to get and keep approval for the device.

Key Documents Needed for Clinical Evaluation Submission

To complete a successful clinical evaluation submission, you need to gather essential documents such as the Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), clinical data, post-market surveillance information, and risk management files. These documents are critical in demonstrating the safety and performance of your medical device.

An up-to-date and well-organized clinical evaluation report medical device documentation ensures smoother approvals and long-term market access.

Let our expertise support you in navigating the clinical evaluation process for your medical device.

icon Clinical Evaluation Plan

A Clinical Evaluation Plan is a key document that explains how the clinical evaluation of a medical device will be done. It outlines the steps, data sources, and goals to show that the device is safe and works as intended. This plan helps in collecting and reviewing clinical data in a clear and organized way. It supports the overall medical device clinical evaluation process and is closely linked to the clinical evaluation report.

icon Literature Search Protocol & Report

As part of the clinical evaluation process, a literature search helps gather proof of how safe and effective a medical device is, without needing to run a new clinical trial. By reviewing published research, articles, and existing clinical data, this method supports the creation of a strong clinical evaluation report. For many medical device manufacturers, this approach saves both time and cost while meeting the latest EU MDR clinical evaluation requirements. It also helps show the clinical performance evaluation of your device clearly, which is key to preparing a reliable clinical evaluation report (CER) for medical devices.

Clinical Evaluation Report

icon Clinical Evaluation Report

A Clinical Evaluation Report (CER) is an important document that shows how safe and effective a medical device is. It includes information from clinical studies, technical data, and other sources to prove that the device works well and is safe to use. The clinical evaluation process involves reviewing existing data from equivalent and similar medical devices to check the clinical performance and benefits of the device. Whether it’s a new product or an update of an existing medical device, having a strong medical device clinical evaluation helps ensure it can be placed safely on the market.

icon Demonstration of Equivalence

In medical device clinical evaluation, showing equivalence means using clinical data from another similar device to support your own device's safety and performance. This helps reduce the need for new clinical investigations. For medical device manufacturers, this approach can save time and effort during the clinical evaluation process. It is especially useful when preparing a clinical evaluation report for a medical device under EU MDR requirements. By using data from an equivalent device, you can build a strong clinical performance evaluation without starting from scratch. It’s a smart way to meet regulatory needs and move forward faster with your MDR clinical evaluation.

Clinical Evaluation Report writing services for Medical Devices

Our CER writers carefully review clinical data from various sources, including clinical settings, research, and best practices, to evaluate the safety and performance of medical devices. Our CER writers are subject matter experts with profound knowledge and understanding to interpret literature and review articles and extract what resonates with a particular medical device. The Clinical Evaluation Reports (CERs) provide clear proof of how a device meets General Safety and Performance Requirements (GSPR), assess its benefit-risk balance, and include post-market surveillance (PMS) activities to ensure the device continues to be safe and effective.

Clinical-Evaluation

CE Marking Consultants

We have a team 20+ talented, skilled & experienced technical consultants. Our CE marking consultants help the manufacturers to place their IVD medical devices on European Market.

Document Control

We take care extra care to maintain control over documentation and client confidentiality which creates value and helps us maintain client’s best interests.

Annual Maintenance

Our Regulatory consultancy provides customizable services to update and maintain your regulatory framework and QMS and complying with the needs of various regulations.

Frequently Asked Questions

To evaluate a medical device, start by conducting a Clinical Evaluation—a structured process to assess the device’s safety, performance, and regulatory compliance. This involves reviewing clinical data, scientific literature, and post-market information. Key documents like the Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), and risk management files are essential. Demonstrating equivalence and analyzing real-world data further support compliance with EU MDR or other relevant regulations. Post-Market Surveillance data further confirms device claims.

Clinical evaluation methods include a thorough analysis of clinical data through three main approaches: (1) a critical evaluation of relevant scientific literature, (2) clinical investigation or trials conducted on the device, and (3) the use of clinical experience or data from equivalent devices. These methods help demonstrate the device’s safety and performance in accordance with regulatory standards such as EU MDR and MEDDEV 2.7/1 Rev. 4.

A clinical evaluation under MDR (Medical Device Regulation) is a systematic process used to assess and analyze clinical data to verify the safety, performance, and effectiveness of a medical device. Required by EU MDR 2017/745, it involves reviewing scientific literature, clinical investigations, and post-market data. The goal is to ensure the device meets General Safety and Performance Requirements (GSPR) and supports its CE marking.

The Clinical Evaluation Plan (CEP) outlines the methodology, objectives, and sources of data that will be used to conduct the clinical evaluation of a medical device. It serves as a roadmap for the evaluation process. The Clinical Evaluation Report (CER), on the other hand, is the final document that presents the results of the evaluation, including analysis of clinical data, demonstration of equivalence, safety and performance conclusions from referred literatures.

The three main methods used in clinical assessment are:

1. Systematic Literature Review – analyzing published scientific data to support device safety and performance.

2. Clinical Investigations – conducting clinical trials or studies to generate new data.

3. Demonstration of Equivalence – comparing the device with an existing, similar device that has sufficient clinical data.

These methods help demonstrate compliance with regulatory requirements and ensure the device’s safety and effectiveness.

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