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Lorem Ipsum Devicev2.3.1The clinical evaluation shall be thorough and objective, and take into account both favorable and unfavorable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device.
The clinical evaluation will take into account the device under evaluation, equivalent or similar devices (as needed), and the state of the art. Clinical data will be gathered from real world data, generated through clinical investigations (if relevant), captured from the scientific literature, or procured through other relevant sources.
The clinical data will be appraised if needed and analyzed in order to reach conclusions regarding the safety and clinical performance of the device including its clinical benefits.
The following regulatory standards or guidance documents are considered relevant to this clinical evaluation and may be covered in full or used to provide input regarding strategy and conclusions.
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According to EU MDR 2017/745, this device is classified as a Class IIa device.
A clinical benefit is defined as the positive impact of a device on the health of an individual, expressed in the 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. Clinical benefits are listed within the Instructions for Use.
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Clinical claims relate to clinical performance or safety of the device and should be supported by appropriate data. All clinical claims related to clinical performance and safety are included below and can come from the IFU or other marketing sources.
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Any additional information including warnings, precautions, and any applicable labels can be found in the Instructions for Use.
A valid clinical association is understood as the extent to which the device's output (e.g. concept, conclusion, calculations) based on the inputs and algorithms selected, is associated with the targeted physiological state or clinical condition. This association should be well founded or clinically accepted (e.g. existence of a scientific framework or sufficient level of evidence). The valid clinical association of a device should demonstrate that it corresponds to the clinical situation, condition, indication or parameter defined in the intended purpose of the device.
It should be noted that the Valid Clinical Association may not always be readily established. Thus, the clinical performance of the device can serve as an additional valid clinical association from a clinical perspective for the specific intended purpose.
The valid clinical association can be considered the following:
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Technical performance is the demonstration of the device's ability to accurately, reliably and precisely generate the intended output from the input data.
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Clinical performance is the demonstration of the device's ability to yield clinically relevant output in accordance with the intended purpose.
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The clinical evaluation will be conducted according to the clinical evaluation plan and SOP Clinical Evaluation. The clinical evaluation will include the processes in order to gather, appraise and evaluate data so that there is sufficient clinical evidence to support the performance and safety of the device. These processes can include but are not limited to:
A systematic review of the literature as well as a review of clinical trial databases and vigilance databases shall be performed in order to gather adequate clinical data on the device under evaluation, the equivalent device (as needed), and the state of the art. The following sections provide an overview on how this will be performed.
Sufficient clinical evidence should be taken to mean that the available clinical data are sufficient in amount and quality to allow a qualified assessment of whether the device achieves its intended clinical benefit(s) and safety when used as intended.
The clinical development plan outlines progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations and a PMCF.
Clinical evidence generation can occur through exploration of scientific literature and device equivalency. All activities must be completed for each development stage prior to entering into the next development stage unless a justification is provided. Optional steps are performed as needed.
Equivalency may be used during the clinical evaluation to support the clinical performance and safety of the device under evaluation. A full equivalency analysis will be performed within the clinical evaluation report. Devices considered for equivalence should be CE marked in the EU or have a justification provided for why a non-CE marked device is used.
The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:
A literature search will be performed using a systematic approach for the gathering, appraisal, and review of scientific literature as it relates to the device under evaluation, the equivalent device, and the state of the art.
The following databases will be queried for literature data
Search terms will be determined using the PICO method. PICO search terms include the following:
The search should be sufficiently broad enough to establish benchmarks, determine the state of the art, risks and potential benefits of the device.
Once literature has been gathered, it is to be appraised for relevance. The literature will undergo two reviews to determine if it meets inclusion or exclusion criteria. The first review will occur for the publication Title and Abstract. The second review will occur for the publication full-text.
Inclusion criteria for the publication are as follows:
Exclusion criteria for publications are as follows:
All literature that is excluded based on exclusion or inclusion criteria should be assigned an exclusion code that best represents why it was removed from consideration for clinical evidence. Exclusion codes are found below.
The level of evidence required for demonstrating clinical performance and safety should be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device.
For this device, according to the level of evidence in the table below (from MDCG 2020-6), clinical data resulting from sources above a "Level 4" are not required due to the low risk of the device. However, the clinical evaluation team will include data from these sources if it is available and relevant. Data from sources of "Level 6" and above is recommended unless otherwise justified.
Once a full-text publication has been identified for being selected for full-text due to inclusion criteria, it will be appraised for relevance. Publications related to the device under evaluation or the equivalent device are considered data pivotal to determining the clinical performance and safety of the device while publications related to the state of the art are considered as supportive data in order to provide benchmark information for the device under evaluation and equivalent device.
The appraisal criteria for the full-text appraisal includes in the following:
The full-text appraisal will be used to determine the weight of the clinical data gathered from the literature search. The lower the score of the appraisal, the higher the weight of the clinical data produced from that literature source. The appraised full-text articles will be captured in the appendix of the clinical evaluation report.
The literature search will be performed using keywords according to the PICO search strategy. The keywords planned to be used for the clinical evaluation can include the following:
lorem, ipsum, dolor, sit, amet, medical device, clinical performance, safety, patient outcomes
Clinical trial registries will be examined for any clinical trials that may provide additional performance and safety information related to the device under evaluation, equivalent device, or the state of the art.
An international clinical trial registry will be probed for clinical trials:
Clinical trials will be searched via clinical trial search keywords. The keywords should attempt to retrieve clinical trials with relevant information regarding the device under evaluation, equivalent device or the state of the art. Clinical trials will be filtered based on inclusion and exclusion criteria.
Inclusion criteria for clinical trials are:
Exclusion criteria for clinical trials are:
Clinical trials identified as relevant will be summarized in the clinical evaluation report and considered for clinical evidence.
Search keywords for clinical trial databases are determined based on the same PICO criteria as used for the literature search terms. The search keywords for clinical trial database can include the following:
dolor, amet, medical device, clinical trial, patient, intervention, outcome
Post-market data will be considered for the clinical evaluation. The device has a post-market surveillance system in place according to SOP Post-Market Surveillance. In addition to any available data from post-market surveillance or complaints, data will be gathered from international vigilance databases on the device under evaluation, equivalent device and state of the art.
Multiple international vigilance databases will be investigated for data relating to the safety of the device under evaluation, equivalent device, and state of the art. The following databases will be searched for any relevant vigilance data:
Vigilance data collected during the search that is related to the device under evaluation, equivalent device, or the state of the art will be reviewed to identify any risks not previously identified in the risk assessment. Additionally, the risk profile of the generally accepted state of the art will be determined to be compared against the risk profile of the device under evaluation.
Vigilance databases will be searched using keywords related to the device under evaluation, equivalent device, and the state of the art. The following keywords can be used as search terms for the international vigilance databases. The most appropriate search terms will be selected and recorded in the clinical evaluation report.
device safety, adverse event, recall, vigilance, medical device, incident, malfunction
The clinical evaluation team shall have the required expertise and experience to appropriately perform the clinical evaluation as described in SOP Clinical Evaluation. The members of the clinical evaluation team include the following people:
Jane Doe, PhD – Clinical Affairs Lead; John Smith, MD – Medical Advisor; Alice Brown, MSc – Regulatory Specialist
Members of the clinical evaluation team declare that there are no potential conflicts of interest that may impact their objectivity during the clinical evaluation. They confirm no financial interests or professional relationships that could compromise the impartiality of the evaluation. The team commits to conducting the clinical evaluation with integrity, adhering to regulatory guidelines and confirming their declaration of interest by signing this document.
Curriculum vitae's for the clinical evaluation team are available upon request.
