CLINICAL EVALUATION

A organized continuous method for collecting, evaluating, and analyzing clinical data relating to a medical device is known as clinical evaluation. The goal of the assessment is to see if the clinical data provided is enough to establish that the device meets the relevant general safety and performance requirements when used according to the manufacturer’s instructions (IFU)

Guidance documents used in addition to MEDDEV 2.7/1 include the following:

  • Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice (EN ISO 14155:2011)

  • Medical Devices – Application of Risk Management to Medical Devices (EN ISO 14971:2012)

  • Post Market Clinical Follow-up – A guide for manufacturers and Notified Bodies MEDDEV 2.12/2 rev2  and MDR Annex XIV

  • Post Marketing Surveillance NB Med 2.12 Rec1 and MDR Annex III

Other standards, such as MEDDEV 2.1/6 Quantification and Classification of Stand-Alone Software, may be useful depending on the type of medical device ( January 2012). The IFU, literature review, clinical investigation reports, risk management reports, and PMS reports were all used as reference sources in generating the Clinical Evaluation report.

DEMONSTRATION OF EQUIVALENCE – CHARACTERISTICS

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● Used for the same clinical condition (including similar severity and stage of disease), and
● Used for the same medical indication, and
● Used for the same intended purpose, and
● Used at the same site in the body, and
● Used in a similar population (e.g. age, gender, anatomy, physiology etc.), and
● Not foreseen to deliver significantly different performances (in the relevant critical performances such as the expected clinical effect, the specific intended purpose, the duration of use, etc.).

● Be of similar design, and
● Used under the same conditions of use, and
● Have similar specifications and properties (e.g. physicochemical properties such as type and intensity of energy, tensile strength, viscosity, surface characteristics, wavelength, surface texture, porosity, particle size, nanotechnology, specific mass, atomic inclusions such as nitrocarburising,  oxidability), and
● Use similar deployment methods (if relevant), and
● Have similar principles of operation and critical performance requirements.

● Use the same materials or substances in contact with the same human tissues or body fluids.

ESSENTIALS IN COMPLETING A CLINICAL EVALUATION REPORT CONCLUSION

Clinical Evaluation Report is a brief summary of the complete process of clinical evaluation and provides the summary of each and every stage. It also comprise the details like, scope of clinical evaluation. The scope of Clinical Evaluation Report includes the details regarding the manufacturer, device description, device classification, intended purpose of the device, contraindications, warnings, precautions, device status which indicates if the device is undergoing the initial CE marking or if it is for a renewal, identification of changes, clinical background, current knowledge, state of art etc.

Complete details about the device under evaluation, demonstration of equivalence if applicable, all data held and generated by the manufacturer (all tests regarding the safety and performance of the medical device), data retrieved from the literature, summary and appraisal of clinical data, analysis of clinical data with regard to safety, performance, undesirable side-effects, risk/benefit ratio and how benefits outweigh risks for the device to be safe.

Clinical Evaluation Report

To conduct the appraisal and analysis of the clinical data of the device or of the equivalent device manufacturer need to review current knowledge and or the state of the art.

The state of the art in the relevant medical field refers to current knowledge in the field, such as applicable standards and guidance documents, information about the medical condition managed by the device and its natural course, benchmark devices, or other devices and medical alternatives available to the target population. Manufacturers and Notified Bodies can use the state-of-the-art description to evaluate the device’s safety and performance.

The clinical background must include a full explanation of the medical disease to be treated, its natural course and implications, and how it will be managed or diagnosed using the investigational device. The prevalence of medical disorders in the general population, which varies by age group, gender, ethnicity, familial predispositions, and genetic features, must be covered, as well as information regarding the various clinical forms, phases, and severities of the medical condition. Data on treatment, management, or diagnostic choices for medical disorders should be explained in historical context and advances, with a review of the pros and downsides of the many alternatives available.

Benefit/risk profiles and restrictions in relation to different clinical forms, phases, and severities of specified medical problems, as well as different target populations The benefits and hazards, including the kind, extent, likelihood, duration, and frequency, must be clearly defined, as well as the acceptability of unwanted side effects, causes of damage, clinical elements of side effect reduction and management, and other risks.

Data generated and held by the manufacturer typically includes all pre-clinical and pre-market clinical investigations, clinical data generated from risk management activities, and the data from PMS which the manufacturer has implemented in European markets or in other countries, such as:

a) PMCF studies including clinical investigations,

b) PMS reports including vigilance reports and trend reports,

c) incident reports sent to the manufacturer by users or reports held by the manufacturer through his own investigations,

d) complaint reports sent to the manufacturer regarding the performance and safety of the device,

e) analysis of explanted devices,

f) details of field safety corrective actions, use of the device under compassionate use,

g) pre-clinical data including bench testing.

The steps of the clinical evaluation procedure for a medical device include literature search, data appraisal, and data analysis of clinical data. The manufacturer will retain certain data about the medical device, such as pre-market clinical investigations, PMCF studies, biocompatibility studies, other user reports, defects in his own device, and so on, which falls under data retrieved from the manufacturer for proving the safety and performance of the medical device. Additional data is necessary to verify the safety and performance of the device in addition to the manufacturer’s data, which will be supplied by a literature search, which is a qualitative approach of proving the safety and performance of a medical device.

A literature search yields a wealth of information on the clinical data of a medical device under assessment or similar/equivalent devices, the clinical backdrop, possible dangers associated with the medical device, the state of the art, and so on. When doing a literature search, a full search protocol should be followed, which involves the creation of an appropriate technique, template, and report. Literature searches may be conducted using a variety of resources, including scientific databases, Google Scholar, and the internet. Once the search has been completed in accordance with the search methodology, its adequacy and any deviations from the search must be confirmed. Included abstracts should be consistent with the data relevant to the equipment under review or a similar/equivalent device.

Appraisal of the clinical data has to be performed for all the literatures which were included in the literature search reports. A proper procedure for performing the appraisal, a template for filling the appraisal has to be included and then the appraisal is performed. The appraisal has to be performed according to the appraisal plan by weighing the data according to the methodological quality, scientific validity, relevance to the device, relevance to intended use aspects of each data set. The appraisal should be thorough and objective and adequate weightage has to be given for both favorable and unfavorable data and the appraisal plan has to be documented in the clinical evaluation report.

Analysis of the clinical data is performed to determine if the appraised data sets comply with all the requirements with regards to the safety and performance of device under evaluation. Analysis should be performed by using sound procedures. This procedure determines if the manufacturer needs to perform any additional testing to satisfy the needs of safety and performance of the device under evaluation and also the needs for Post Market clinical follow-up. The end result of analysis should prove that the benefits of the medical device outweighs risks for a medical device with regards to the safety and performance as specified by the manufacturer.

Clinical Data for a medical device appraised in stage 2 of the clinical evaluation process should be analyzed in stage 3 to demonstrate compliance with all the Essential Requirements confirming the safety and performance of the device during its use for the intended purpose. In order to demonstrate compliance, the clinical evaluators should follow some specific considerations, such as sound methods, making a comprehensive analysis, determining additional clinical investigations and PMCFs if required.

  1. The methods available for analyzing clinical data are mostly qualitative or quantitative, depending on the nature of the medical device and the circumstances. Qualitative methods are more reliable.
  2. Make a comprehensive analysis by determining compliance with each of the Essential Requirements pertaining to the safety, acceptable benefit/risk profile, and performance of the device, which are explained in detail below:

Conformity assessment with requirements on safety in accordance with MDD ER1 / AIMDD ER1. The information provided by the manufacturer, including IFU, labels, and other promotional materials, should be reviewed to ensure consistency with clinical data appraised in stage 2, and all related hazards, risk mitigations, and other clinically significant information should be identified.

Conformity assessment with requirements for an acceptable benefit/risk profile per MDD ER1 / AIMDD ER1.  Any risks associated with the intended purpose must be low and acceptable when weighed against the patient’s benefits, and they must be compatible with a high level of protection for their health and safety. Following points needed to keep in mind:

  • The IFU perfectly describes the device’s intended use and demonstrates it with sufficient clinical evidence.
  • IFU must contain correct information, like handling instructions, descriptions of risks, warnings, precautions, contraindications, instructions for managing foreseeable unwanted situations to reduce the risk and their management and needs to be supported by sufficient clinical evidence.
  • A description of the device’s intended purpose and the device’s benefits to the patient should be reviewed per the IFU provided by the manufacturer and supported by sufficient clinical evidence.
  • Evaluation of the clinical risks of devices should be performed by description of risk management, incidents reported in PMS, and also the extent of risk, which includes the nature of severity, number, and rates of adverse events.
  • Assessment of the risk-benefit profile’s acceptability.

Conformity assessment with requirements for performance: The ability of the device to achieve its intended purpose should be demonstrated, including direct or indirect effects, along with clinical benefits. The clinical data of the device achieves its intended performance during normal conditions of use.

Conformity assessment with requirements on acceptability of undesirable side- effects is done by weighing acceptable undesirable side effects against the intended performance. The acceptability of the side effects of a device should be evaluated on the basis of the information given below:

  • Evaluation of clinical data on the nature, severity, and frequency of the side effects.
  • The clinical data should include a sufficient number of observations (e.g., from clinical investigations or PMS) to ensure the scientific validity of the findings about unfavorable side effects and device performance.
  • To determine acceptability, consider the state of the art, properties of benchmark devices and medical alternatives, and objective performance requirements for standards.

Additional clinical investigations or other measures are necessary to determine if they are needed in order to generate any missing data and eliminate compliance difficulties.

To determine the PMCF’s requirements, assessors should describe all residual risks, uncertainties, or unanswered questions.

NOTIFIED BODY REVIEW OF CLINICAL EVALUATION REPORT

A ‘Notified Body’ is a conformity assessment body designated in accordance with the EU Regulations. The notified body is responsible for assessing and verifying clinical evaluation reports and supporting technical documentation submitted by medical device makers in order to demonstrate a product’s conformance to the GSPR. Notified Body conducts a conformity assessment which usually involves a review of the manufacturer’s quality system and a review of the relevant technical documentation, including a clinical evaluation report provided by the manufacturer to confirm the safety and performance claims for the device.

The notified body is involved in the review of devices higher risk class (Is, Im, Ir, IIa, IIb & III). The clinical evaluation report is assessed by the notified body according to the General Safety and Performance Requirements (GSPRs) given in the EU Regulations. When the Notified Body determines that a manufacturer has met the applicable assessment criteria, they grant a CE certificate indicating that the products under evaluation have fulfilled the standards.

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MEDDEV 2.7.1 Revision 4

MDR Article 61

On July 1, 2016, the European Commission published Revision 4 of the Clinical Evaluation Guidance Document MEDDEV 2.7.1.

Clinical Evaluation Assessment Report

MEDICAL DEVICES

A clinical evaluation assessment report (CEAR) is a document used by the notified body to clearly document its assessment of the clinical evidence presented by the manufacturer in the clinical evaluation report (CER) and the related clinical evaluation that was conducted – a requirement of the Medical Device Regulation (EU) 2017/745. (MDR).

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