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Clinical Evaluation of Medical Devices
Clinical evaluation is the proactive, continuous assessment and examination of medical device clinical data using scientific methods to determine their safety and efficacy about their intended purposes and claims made by the manufacturer. The clinical evaluation should begin at the development stage and continue throughout the life cycle of medical devices.
As a medical device manufacturer, it is imperative to continually assess the safety and efficacy of your medical device and compile a conclusion report. These reports serve as proof of adherence to regulations.
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Medical Device Clinical Evaluation and European Regulatory Framework
Clinical evaluation is an important part of conformity assessment for all medical devices, regardless of which risk classification they fall under. It is also closely linked to the risk management process and post-market surveillance activities. This page will clarify and emphasize these parallels throughout each process step.
Let’s begin by clarifying the regulatory background and key terminologies for medical device regulations, and other documents, all of which manufacturers must consider throughout the process. As per the medical device regulation, MDR clinical data refers to any data about the safety and performance of a medical device and can be obtained from multiple sources.
The most powerful and determining data sources are derived from well-designed clinical investigations of the device in question. However, before beginning to plan such an investigation, manufacturers must first identify any current existing data that may be relevant to determining the safety and performance of the device.
Clinical investigations reported in the scientific literature of a similar device. These similarities will be discussed in detail later on, published scientific literature from other experiences or usages, indications of the device in question, or a relevant similar device. Once a device is on market data from the post-market surveillance activities, particularly post-market, clinical follow-up efforts must also be included in the CER.
Before clinical evaluation begins, several essential prerequisites must be met. The intended use must be clearly defined in terms of the target patient population, and a thorough risk assessment must be conducted to define safety claims resulting from a full benefit-risk analysis of the medical device within the defined intended use.
Contact us for genuine EU 2017/745 clinical evaluation of medical devices in line with article 61 and MEDDEV 2.7.1 Rev 4 and ISO 14144 standards. We provide end-to-end solutions for small, medium, and large-scale medical device manufacturers across the globe.
Understand why Clinical Evaluation is a key component of MDR 2017/745 Technical Documentation
Clinical evaluation is a key component of the EU MDR 2017/745 technical documentation. There are several reasons why it is required:
- It determines the scientific validity of the device by examining clinical data from multiple sources, such as clinical investigations, published literature, post-market surveillance, and post-market clinical follow-up. This process guarantees that the device’s safety, performance, and clinical benefits claims are substantiated by solid, documented proof.
- Clinical evaluation and risk management processes and interrelated. Risk management helps identify, evaluate, and mitigate potential risks associated with the device. By analyzing clinical data, the risk-benefit profile of the device can be estimated, thereby making decisions on risk management strategies and patient safety.
- Article 61 emphasizes the need for ongoing evaluation, particularly through post-market surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). This continuous monitoring helps identify new risks and ensures that the device remains safe and effective throughout its lifecycle even after being placed on the market.
- The evaluation must demonstrate that the device is safe and effective for the intended user population and clinical indications. This is critical for ensuring that the device performs as expected in real-world settings, reducing the likelihood of adverse events or ineffective treatment
- It must provide a detailed justification of equivalence/similarity, comparing the technical, biological, and clinical characteristics of the devices. This process assures the transferability of clinical data from the equivalent device to the device in the scope.
- The findings from the evaluation lead to decisions on device labelling, instructions for use, contraindications, and precautions. It also helps notified bodies assess whether the device should be approved for market entry or continued use
- The MDR technical documentation with detailed evaluation supports the device’s safety and performance claims. This helps notified bodies review the evaluation methods established as part of the conformity assessment process
- Important for monitoring the safety and performance of a device after it has been approved for use
- A well-conducted evaluation enhances transparency, providing healthcare professionals, patients, and NBs with confidence in the device’s performance and safety.
We are a team of regulatory professionals and CER writers. We solve every obstacle in the path of MDR Article 61 and MEDDEV 2.7/1 Rev. 4 compliance. We provide end-to-end solutions for small, medium, and large-scale medical device manufacturers across the globe. Our CER writers and experts have a deep understanding of the MDR article 61 requirements, including the specific requirements of different notified bodies. This experience is essential for ensuring that the documentation is accepted by the notified bodies.
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Clinical Evaluation Process
The clinical evaluation process is a systematic and ongoing assessment of clinical data to verify the safety and performance of the device throughout its lifecycle. Here’s an overview:
- Through understanding Regulation: EU MDR 2017/745 article 61 section dealing with clinical evaluation and MEDDEV 2.7.1 Rev.4 guidance document
- Clinical Evaluator: Identify a Clinical Evaluator who must have training and experience in the device under evaluation.
- Interpretation of Preclinical Data: The preclinical testing data to determine the performance and safety based on the benchmark values
- State of the Art: As per 2017/745, the CER must demonstrate the state-of-the-art thorough analysis of various parameters and technologies used for similar devices across the globe.
- Equivalent Device: Devices with the same intended use, same technological characteristics, and biological aspects are considered as equivalent device
- Scientific Literature Search: Scientific literature is a permanent record of collective achievements based on the study, and it is the primary medium for communicating the findings of scientific research.
- Sufficient Clinical Data Collection: Sufficient clinical data are described as data relating to safety, performance, and side effects in medical equipment in the way they are intended to be used from human clinical studies for the topic, basic devices, or equivalent technology.
- Technical Documentation: Technical documentation covers CER in 2017/745 and has been connected through the conformity procedure.
- Post-Market Data: Post-market activities are essential for generating clinical data about medical devices, which can help discover uncommon occurrences and accidents that were previously unknown.
We provide comprehensive clinical evaluation document writing services with the guarantee of Notified Body approval. We accept all types of risk classes.
How Important MEDDEV 2.7.1 Revision 4 Guidance Document in the Conduct of Clinical Evaluation?
MEDDEV 2.7/1 Rev.4 guides the manufacturers on how to undertake a robust and systematic clinical evaluation and how to demonstrate the scientific validity of the data and conclusions. The important changes and corrections in Rev. 4 are below.
- Frequency of updates of the CERs (clause 6.2.3)
- Qualification of the clinical evaluators or authors (clause 6.4)
- Requirement of specific objective for the CER Consultants which is to be linked to safety performance and risk-benefit endpoints (section 7 and appendix 5)
- Establishing the State of the Art (clause 8.2)
- Requirement of the scientific validity of the different types of dataset (sec 8,9,10 & Appendices: 5,6 & 7)
- Detailed information on the demonstration of equivalence (appendix 1)
- Information on when a clinical investigation is required (Appendix 2)
- Some detailed information on risk-benefit (appendix 7.2)
- Reinforced PMS and PMCF with the clinical evaluation (throughout the guideline)
- Role and actions required by the notified bodies (appendix 12)
Consultants Roles and Responsibilities in the Clinical Evaluation Documentation and Reporting
We at I3CLOBAL help manufacturers navigate the complex regulatory landscape and ensure the clinical evaluation documentation meets all the requirements. Our medical device consultants have cross-platform expertise and in-depth knowledge of MDR Article 61 and Meddev 2.7/1 Rev.4, so you can start a project right away!
Trying to do it in-house could involve employee hiring, training, and providing the support they need, all of which will cost you time, money, and finally no assurance of success.
We provide comprehensive document writing services with the guarantee of Notified Body approval. We accept all types of risk classes.
Post Market Clinical Investigation
Post market clinical follow up is an integral part of new MDR documentation. Clinical Investigation is a part of Post market Investigation. It is a systematic study performed in humans to access the safety and performance of medical devices based on the comprehensive analysis of available pre-clinical, (Safety), and post-market data relevant to the intended purpose of the device.
Clinical investigation carried out in human subjects to assure the safety and performance of a medical device meet the manufactures intended claim. It is my understanding the device to be investigated can be a new medical device or a device already in the market.
A clinical investigation is considered as the back born with data to prove safe use of device. Results of the investigation moved to CER to demonstrate safety and performance. ISO 14155:2011 addresses good clinical practice to perform Clinical Investigations.
Under the EU MDR, clinical investigations are required for high-risk devices and for devices where existing clinical data is insufficient. These investigations must be designed and conducted according to the MDR’s requirements, including ethical considerations, robust study design, and appropriate data collection methods. The results must be included in the evaluation.
Frequently Asked Questions
Who is responsible for conducting the clinical investigation?
The device manufacturer is responsible for conducting the investigation. This process should involve qualified individuals with expertise in the device usage and regulatory requirements.
What does the EU MDR 2017/745 require for clinical evaluation?
The EU MDR 2017/745 requires manufacturers to conduct a clinical evaluation as part of the technical documentation, specifically under Article 61. This evaluation must include clinical data gathered from clinical investigations, published scientific literature, or post-market surveillance (PMS).
What is the purpose of a clinical investigation under the EU MDR 2017/745?
The purpose of an investigation is to systematically assess and analyze clinical data to verify the safety and performance of a medical device. It ensures that the device meets the GSPR outlined in Annex I of the MDR, demonstrating that the device performs as intended and is safe for its intended use.
What is the role of equivalence in clinical evaluation?
Equivalence allows manufacturers to use clinical data from a similar, already-marketed device to support their evaluation. However, the manufacturer must provide a detailed justification that demonstrates the equivalence of the devices in terms of technical, biological, and clinical characteristics.
How often should the clinical evaluation be updated?
The evaluation should be updated continuously throughout the lifecycle of the medical device. This must be submitted to the notified body during the annual surveillance audit. The frequency of updates depends on factors like the risk class of the device, changes to the device, new clinical data, and feedback from post-market surveillance activities.
What is Post-Market Clinical Follow-Up (PMCF), and why is it important?
Once the device is on the market the Post-market clinical Follow-Up (PMCF) starts and continues collecting clinical data after the device has been placed on the market. PMCF aims to monitor the long-term safety and performance of the device, identify any emerging risks, and ensure that the device continues to meet regulatory requirements. PMCF updates and conclusions must be reviewed by notified bodies during surveillance audits.
How does the clinical evaluation relate to the technical documentation?
What are the consequences of an insufficient clinical evaluation?
An insufficient evaluation can lead to delays in obtaining technical file clearance and thereby CE Certification.
How does the EU MDR affect legacy devices and their clinical evaluations?
Legacy devices, which were approved under the previous Medical Device Directive (MDD), must update evaluation in line with the new MDR requirements. Manufacturers of legacy devices need to ensure that their clinical data meets the additional requirements and sometimes additional data collection, or an investigation is essential.
What is Clinical Trials?
Clinical Trials are scientific investigations to determine the performance, safety, and potential hazards of using a medical device on humans. Clinical trials generate high-quality data that may be used to make healthcare decisions. Clinical trials are the last stage of the research and development process before they are tested on people.