Manufacturers: time to shape up your CERs

 

Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device.

Clinical evaluation is an essential prerequisite for risk management. It justifies the assumptions made in the risk management file, with respect to the benefits and thus the acceptance of a certain risk-benefit ratio.

When looking at the clinical evaluation of a new device, the available data will typically be limited. The evaluation will be based on the best available data at the time; however, the best indication of safety and performance will only be obtained once the device is in use. With the increasing lifespan of devices on the market, there will be increased need for clarity regarding the risk/benefit profile of the device.

IZiel completes the Clinical Evaluation Report (CER) as per the following changes in revision Med-Dev Rev. 4 with focus on detailing and clarity on every step of the clinical evaluation process that has been conducted by the manufacturers and evaluators.

  1. Frequent updates: For all devices, every time there is change in the information available on the device based on post-marketing surveillance (PMS) that affects the evaluation or conclusion of the device, the CER needs to be updated. For high-risk devices, CERs need to be updated annually at the minimum, while low-risk and well-established devices can update CERs every 2-5 years.
  2. Demonstrate scientific accuracy: Greater emphasis has been placed on establishing the scientific validity of the data for each stage of the entire process of clinical evaluation: weighting the data, literature search, retrieval methods, data appraisal, its analysis and weighting it, 
  3. Qualifications of evaluators: A higher education degree and 5 years of professional experience, or 10 years of professional experience where the degree is not a prerequisite has been introduced as a pre-requisite. Deviations from these need to be document justifiably. A declaration of interest for all evaluators is a must as well.
  4. Measurable objectives for CER: The objectives of the CER must be clearly linked to specific endpoints on the safety, performance, and risk-benefit aspects.
  5. Establishing equivalent: Risks-benefits, safety and performance of the claimed equivalents need to be established in greater detail.

In line with the expectations of the European Authorities, clarity and structure are at the core of everything we do at IZiel. Ensuring thoroughness and scientific accuracy at every step of collating data and presenting it in the CER are our prime objectives, and receiving approval is the clear endpoint for every report we create. EU MDR identifies the use of clinical investigations as a method of assessing the benefit-risk ratio of medical devices. Additionally, risk assessment is useful to justify any foreseeable risks to trial subjects when weighed against the benefits. These should be well-documented in the clinical investigation plan. The plan is also required to include an ongoing monitoring strategy for the risks and the benefit-risk ratio.


Comments

Post a Comment

Popular posts from this blog

Clinical Evaluation Report for Medical Devices

A Clinical Evaluation Report (CER) for medical devices is a comprehensive document that assesses the safety and performance of a medical device through the review and analysis of clinical data. The purpose of a CER is to demonstrate the device's conformity with relevant regulations, standards, and requirements, such as the Medical Device Regulation (MDR). A well-prepared CER plays a crucial role in gaining regulatory approval and ensuring the device's ongoing compliance throughout its lifecycle. Here's an outline of the key components typically included in a Clinical Evaluation Report : 1. Device Description and Intended Use :    - Provide a detailed description of the medical device, including its specifications, intended use, and indications for use.    - Clearly define the device's intended purpose, patient population, and the medical condition it is intended to address 2. Clinical Literature Review :    - Conduct a systematic and thorough r...
Read more

Navigating the Maze: Understanding Clinical Evaluation Reports for Medical Devices

In the realm of medical devices, ensuring their safety and effectiveness is paramount to safeguarding patient health. Clinical Evaluation Reports (CERs) play a pivotal role in this process, providing a comprehensive assessment of a medical device's clinical performance. This blog aims to demystify the world of Clinical Evaluation Reports, shedding light on their significance, components, and the intricate process involved in their creation.   What is a Clinical Evaluation Report (CER) ?   A Clinical Evaluation Report is a systematic and critical analysis of clinical data pertaining to a medical device. It is a crucial component of the regulatory submission process, providing evidence that supports the device's safety and performance throughout its lifecycle. The goal is to ensure that the benefits of the medical device outweigh any potential risks.   Key Components of a CER:   1. Device Description:    - Begin with a detailed description ...
Read more

The Significance of Clinical Evaluation Reports in Medical Device Assurance

 As the medical device industry advances, the focus on patient safety and efficacy becomes increasingly paramount. The Clinical Evaluation Report (CER) is central to ensuring medical device performance and safety. This comprehensive document plays a pivotal role in providing a systematic and objective assessment of a medical device's clinical performance, confirming its conformity with regulatory requirements, and ultimately contributing to improved patient outcomes.   Understanding the Clinical Evaluation Report :   A Clinical Evaluation Report (CER) is a thorough analysis and appraisal of clinical data related to a medical device. This process involves the systematic collection, appraisal, and analysis of clinical evidence pertaining to the safety, performance, and intended use of the device. Key components of a CER include:   1. Clinical Data Collection:    - Gathering clinical data from various sources, including clinical investigations, p...
Read more