Clinical Evaluation Plan and Report For Medical Devices

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What is a Clinical Evaluation?

The European Medical Device Regulation (MDR) defines clinical evaluation as a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer (MDR, Article 2). The process is required for medical devices that are intended to be marketed in the European Union.

Generating clinical evidence is critical to demonstrating conformity with the relevant general safety and performance requirements in Annex I of the MDR. The extent of clinical evidence required depends on the characteristics of the device and its intended purpose.

The clinical evaluation process begins during the development of a medical device and continues throughout its lifecycle.

Clinical Evaluation Process

Clinical Evaluation Plan

Manufactures are required to document a clinical evaluation plan for the medical device under development. In accordance with Part A of Annex XIV in the MDR, the Clinical Evaluation Plan shall include, at a minimum:

The General Safety and Performance Requirements that require clinical data for support;
Intended Purpose, Intended Target Groups, Indications, Contra-Indications;
Description of the clinical benefits include the clinical outcome parameters;
The methods that will be employed to assess both qualitative and quantitative aspects of the device’s clinical safety. This must also include clear guidance on how residual risks and side-effects will be determined and evaluated;
List of factors or considerations that will be used when evaluating the benefit-risk ratio. The parameters, methodology, and criteria for assessing the acceptability of the benefit-risk ratio for the indications and intended use of the device based on the current state-of-the-art knowledge;
Indicate how benefit-risk issues associated with specific components used in the medical device (e.g., pharmaceutical substances, non-viable animal tissues (e.g., collagen), or human tissue (e.g., allografts)) will be identified and addressed;
The clinical development plan and post-market clinical follow-up (PMCF) with milestones and potential acceptance criteria.

Identifying Available Clinical Data

After a clinical evaluation plan is developed, the next step is to collect clinical data to establish evidence for the safety and performance of the medical device based on the methods defined in the plan. There are various types of clinical data which can be categorized into two main categories: pre-market clinical data sources and post-market clinical data sources.

Pre-market Clinical Data

Manufacturers can leverage the following types of pre-market clinical data to prove the safety and performance of the device under development in compliance with the relevant general safety and performance requirements.

Clinical investigation reports or other studies in scientific literature for an equivalent device based on the equivalency requirements specified in the MDR:
Peer-reviewed scientific literature on additional clinical experience with the device or equivalent device.
Clinical investigation reports regarding the device (Class III and implantable devices except for a few instances when modifications are made to an existing marketed device. More details can be found in Article 61 of the MDR.).
Other clinical data derived from compassionate or humanitarian exceptional use.

Post-market Clinical Data

Data collected after a medical device receives the initial CE marking is considered post-market clinical data. Clinical data can be collected in various ways including complaints from post market surveillance (clinical data, complaints, incidents), post-market surveillance clinical follow-up studies, literature, and device registries. Collecting post market clinical data is important to maintaining the safety and performance of a medical device throughout its lifecycle.

Clinical Data Appraisal

All collected clinical data should be appraised to evaluate the level of evidence, strengths, and shortcomings in proving a medical device’s safety and performance. Data appraisal is important because the level of quality can vary between the data collected from different sources. The MDR requires the manufacture to use verified or validated assessment tools to appraise clinical data. Examples of verified/validated tools include published clinical data quality assessment tools developed by medical researchers and scientists, such as Cochrane Collaboration’s tool for Randomized Controlled Trials, and Newcastle-Ottawa Scale for assessing the quality of nonrandomized studies in meta-analysis. More information on verified/validated tools can be found in the MDCG 2020-6 guidance document.

Analysis of Clinical Data

After the clinical data is appraised, it is analyzed to demonstrate conformity with the relevant general safety and performance requirements. The manufacturer’s clinical data analysis should include all relevant clinical data (both favorable and unfavorable):

Demonstration of medical device’s clinical benefits.
Evaluation of clinical data against the risk management requirements in the MDR.
Demonstration that clinical evidence obtained meets the relevant general safety and performance requirements.
Confirmation that a Gap analysis was performed to determine if additional clinical data is needed.

Clinical Benefits

The manufacturer must demonstrate the clinical benefits associated with the medical device. The MDR defines clinical benefit as the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health (Article 61, MDR).

Risk and Benefit-Risk Determination

Clinical data analysis and risk management are closely linked. The manufacturers should review the risks identified from their risk management process and evaluate which risks require generation of clinical data to justify the probability and severity of a particular harm or the effectiveness of a risk control measure. The manufacturer must then assess if the clinical data satisfies the risk control requirements. Clinical data must also be used in the benefit-risk determination of the device, which is the evaluation of all appraisals regarding the benefits and risks for utilizing the device as intended considering the state-of-the-art in medicine. More details can be found in the MDCG 2020-6 guidance document.

Clinical Evidence

During data analysis, the manufacturer is required to justify the level of clinical evidence required to conform to the relevant general safety and performance requirements. Validated quality assessment tools developed by medical researchers and scientists should be used to reach determination of sufficiency. Examples of the tools can be found in the MDCG 2020-6 guidance document.

Gap Analysis

During data analysis, a gap analysis should be conducted to determine if the collected data is sufficient in establishing safety and performance of the device. If there is a lack of sufficient evidence, more clinical evidence may be required by doing further research, conducting pre-market clinical investigations, or performing PMCF studies. Details on gap analysis can be found in the MDCG 2020-6 guidance document.

Clinical Evaluation Report

Clinical evaluation results detailing the clinical evidence for the safety and performance of the medical device and conformity with the relevant general safety and performance requirements must be documented in a clinical evaluation report. The clinical evaluation report content includes important information such as device description, clinical literature review, clinical investigations and related documents, post market surveillance and PMCF, summary and conclusion of all available data, and an overall conclusion. Details on the content of the clinical evaluation report can be found in the clinical evaluation assessment report template on the European Commission website.

Why Choose Innovenn for Clinical Evaluation?

At Innovenn, we understand the importance of clinical evaluation in the medical device development process. Our team of experts has experience in reviewing clinical evaluations for a wide range of medical devices. We are committed to providing our clients with the best possible support throughout the clinical evaluation process.

To learn more about Innovenn’s Clinical Evaluation consulting services, contact us to discuss your specific needs.

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