Kolabtree | www.kolabtree.

com

This is a sample of a Clinical Evaluation Report for

informational purposes only and is intended as a guidance
document for medical device companies. It has been
prepared by Kolabtree consultant and CER expert Girish
Hirpara.
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TEMPLATE OF
CLINICAL EVALUATION REPORT
FOR
[DEVICE NAME]
CER ID NUMBER:

Confidentiality Statement
The information in this document contains trade secrets and commercial information that are
privileged or confidential and may not be disclosed unless such disclosure is required by
applicable law or regulations. In any event, persons to whom the information is disclosed must
be informed that the information is privileged or confidential and may not be further disclosed
by them. These restrictions on disclosure will apply equally to all future information supplied to
you which is indicated as privileged or confidential.

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1. TABLE OF CONTENT
Contents
1. TABLE OF CONTENT ............................................................................................................................ 3
2. EXECUTIVE SUMMARY ........................................................................................................................ 6
3. SCOPE OF THE CLINICAL EVALUATION ................................................................................................ 7
3.1 Objective ..................................................................................................................................... 7
3.2 Subject Device Overview and Regulatory History ....................................................................... 8
3.2.1 Identification of device(s) .................................................................................................... 8
3.2.2 Identification of manufacturer ............................................................................................ 8
3.2.3 Governing directive ............................................................................................................. 8
3.2.4 General Device description ................................................................................................. 8
3.2.5 Intended use/purpose ......................................................................................................... 9
3.2.6 Device claims ....................................................................................................................... 9
3.2.7 Status of the device ............................................................................................................. 9
3.2.8 Device Change History ........................................................................................................ 9
3.2.9 Identification of changes ..................................................................................................... 9
3.2.10 Other aspects .................................................................................................................... 10
3.3 Current Clinical Evaluation Route of Conformity....................................................................... 10
4 CLINICAL BACKGROUND, CURRENT KNOWLEDGE, STATE OF THE ART ............................................. 11
4.1 Literature Search Methods ....................................................................................................... 11
4.2 Clinical Background ................................................................................................................... 11
4.3 Treatment Development ........................................................................................................... 11
4.4 Currently Available Treatment Options..................................................................................... 11
4.5 State of the Art Discussion ........................................................................................................ 11
4.6 Alternative Treatment Methods ............................................................................................... 11
4.7 Conclusion................................................................................................................................. 12
4.8 References ................................................................................................................................ 12
5 SUBJECT DEVICE UNDER EVALUATION .............................................................................................. 13
5.1 Subject Device Description and Specifications .......................................................................... 13
5.1.1 Required and Adjunctive Devices and Accessories Not Included in CER Scope ................. 13
5.1.2 Intended Purpose .............................................................................................................. 13
5.1.3 Clinical Claims.................................................................................................................... 13

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5.1.4 Indications ......................................................................................................................... 13

5.1.5 Contraindications .............................................................................................................. 13
5.1.6 Adverse Events / Side Effects ............................................................................................ 13
5.1.7 Warnings and Precautions ................................................................................................ 13
5.1.8 Device Lifetime / Duration of Use ..................................................................................... 13
5.1.9 Magnetic Resonance Imaging (MRI) Compatibility............................................................ 13
5.1.10 Sterility .............................................................................................................................. 13
5.1.11 Materials and Biocompatibility ......................................................................................... 13
5.1.12 Principles of Operation ...................................................................................................... 13
5.2 Type of evaluation..................................................................................................................... 13
6 EQUIVALENCE ................................................................................................................................... 15
6.1 Equivalent Device Description................................................................................................... 15
6.2 Equivalence Table (Below mention tables can be modify as per subject device requirements) 15
6.2.1 Clinical Equivalence ........................................................................................................... 15
6.2.2 Technical Equivalence ....................................................................................................... 15
6.2.3 Biological Equivalence ....................................................................................................... 16
6.3 Equivalence Rationale ............................................................................................................... 16
6.3.1 Summary of Differences .................................................................................................... 16
7 DATA SOURCES - IDENTIFICATION AND APPRAISAL (STAGE 1, 2)...................................................... 17
7.1 Data Appraisal Plan ................................................................................................................... 17
7.1.1 Non-Clinical Data ............................................................................................................... 18
7.1.2 Clinical Data....................................................................................................................... 19
7.1.3 Literature Review Conclusions .......................................................................................... 25
8 POST-MARKET EXPERIENCE AND SURVEILLANCE (PMS) ................................................................... 26
8.1 Complaint and Vigilance Data ................................................................................................... 26
8.1.1 Overall Complaints/ Sales Data [IF Applicable] ................................................................. 26
8.1.2 Overview of Complaint Rate ............................................................................................. 26
8.1.3 Complaint Monitoring ....................................................................................................... 26
8.1.4 Complaints Data by Category ............................................................................................ 26
8.1.5 Analysis of the Top 4 Product Experience Codes ............................................................... 26
8.2 Overall Complaint Analysis Conclusions .................................................................................... 26
8.3 External Vigilance Data or Adverse Event Databases ................................................................ 26

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8.3.1 External Vigilance Data or Adverse Events Databases Results Summary .......................... 28
8.4 Post Market Surveillance Report Conclusion ............................................................................ 28
9 BENEFIT / RISK ANALYSIS .................................................................................................................. 29
9.1 Clinical Benefits / Performance Analysis ................................................................................... 29
9.2 Clinical Risks / Safety Analysis ................................................................................................... 29
9.2.1 Patient Harms (from Risk Management Documentation) ................................................. 29
9.2.2 Risks Identified in the Clinical Data ................................................................................... 29
9.3 Benefit-Risk Profile Acceptability .............................................................................................. 29
9.4 Requirement for Post Market Clinical Follow-up (PMCF) .......................................................... 29
10 CONCLUSION................................................................................................................................. 30
11 CER FREQUENCY............................................................................................................................ 31
12 APPENDICES .................................................................................................................................. 32
13 ABBREVIATIONS ............................................................................................................................ 33
14 QUALIFICATION OF THE RESPONSIBLE EVALUATORS (INCLUDING CV) ......................................... 34
15 REFERENCES .................................................................................................................................. 35
16 CER SIGANTURE AND DATE ........................................................................................................... 36

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2. EXECUTIVE SUMMARY

This clinical evaluation report for [Name of the Device] is an initial/change/line

extension/periodic update/triggered update. The current clinical evaluation is performed for
the demonstration of conformity with General Safety and Performance Requirements for the
medical device(s) in accordance with the Annex I EU MDR 2017/745 and IMDRF MDCE
WG/N56FINAL:2019.
[Name of the Device] has been on the market for [xx] years. The first CE mark for [Name of the
Device] was acquired on [dd-mmm-yyyy]. Cumulatively, [number] units have been sold
worldwide.
This CER is based on the evaluation of data generated and held by [Company Name], from
[pre-market clinical investigations, clinical data from risk management activities, pre-clinical
studies, and post market surveillance (PMS) programmes like post market clinical follow up
(PMCF), PMS reports including vigilance reports and trend reports, literature search reports,
incident reports, field safety corrective actions (include as applicable from the list)].
The benefit/risk profile of [Name of the device(s)] is acceptable according to the current
knowledge/state of the art and other available medical alternatives.
A comprehensive review and analysis of all the data generated and held by [Company Name] on
[Name of the device], did not find any additional new harms and there were no unacceptable
risks associated with the device during the time frame of this CER. All the risks identified were
reduced to the lowest level possible by means of adequate risk control measures.
The device design and materials are evaluated and approved in accordance with the [Company
Name] product development processes. The device(s) employ materials whose safety and
biocompatibility is well understood and accepted for medical products.
Overall, the data evaluated for this CER show that the [Name of the device(s)] is/are safe and
effective when used in accordance to the intended use. The analysis of risks and benefits of
[Name of the device(s)] demonstrates that the benefits outweigh the risk, when used as
indicated.

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3. SCOPE OF THE CLINICAL EVALUATION

3.1 Objective
The scope of this clinical evaluation is applicable to the [Name of the Device].

The objective of the clinical evaluation process is to establish conformity with the relevant
general safety and performance requirements set out in Annex I MDR 2017/745. The planning
and execution of the clinical evaluation is conducted in accordance with the principles of
accordance with MDR 2017/745 Annex-XV Clinical Evaluation and IMDRF MDCE
WG/N56FINAL:2019 and MEDDEV 2.7/1 (Revision 4), Guidelines on Medical Devices, “Clinical
Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and
90/385/EEC” as well as internal procedures and templates.

The scope of this clinical evaluation is based upon the relevant general safety and performance
requirements set out in Annex I MDR as specified by but not limited to MDR 2017/745 Annex-I
and XV Clinical Evaluation that must be addressed from the clinical perspective, with
consideration of the nature and history of the [Name of the Device]. This clinical evaluation
identifies, appraises, and analyses favorable and unfavorable information. The following
outlines the aspects considered in this CER:

a) Device description.
b) Design features of the device, indications for its use, or target populations that require
specific attention, including any safety or performance concerns, contraindications, and
precautions, method of application and claims about the safety and performance of the
device.
c) Risk management documents associated with the device, identifying the risks associated
with the device and how these risks have been addressed. The significance of any
clinical risks that remain after design risk mitigation strategies is conducted.
d) Current knowledge and state of the art in the field, including applicable standards and
guidance documents, information relating to the medical condition managed by the
device, the natural course of the condition, benchmark devices and other devices and
alternatives available to the target population.

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e) Introduction or planned introduction of any clinically relevant (non-administrative)

design changes, changes to materials and/or manufacturing processes, and changes to
informational materials such as the label, Instructions for Use (IFU), or promotional
materials.
f) Information on any specific clinical concerns that have more recently emerged and
should be addressed.
g) Post-market surveillance (PMS) aspects that require updates in this CER.
h) Needs for planning PMS activities.
i) Review of relevant literature and analysis of clinical data.
j) Assessment of benefit: risk ratio.

3.2 Subject Device Overview and Regulatory History

3.2.1 Identification of device(s)

Product
 Mention all devices covered by this clinical evaluation report, products, models, sizes, software
versions, accessories, their proprietary names, code names assigned during device development
Classification and Product Identification
 Risk class, 510(k) number, UMDNS; GMDN, etc.

3.2.2 Identification of manufacturer

Legal Manufacturer
 Name and address of the manufacturer.

3.2.3 Governing directive

Medical Device according to
AIMDD as amended by directive 2007/47/EC
MDD as amended by directive 2007/47/EC
MDR 2017/745
 delete if not applicable

3.2.4 General Device description

Description in alignment with technical documentation
 Device Model/Variant,
 Device Size,
 UDI-DI Number,
 Software Version (If Applicable)
 Device Codes Number,
 Concise physical and chemical description, including materials;

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 Picture or drawing of the device.

Reference to technical documentation
 Reference

3.2.5 Intended use/purpose

Intended use/purpose in alignment with Instructions for use (IFU)
 Exact description of the intended purpose as described in the device's IFU ( In exceptional cases where
an instruction for use is not required, describe the generally recognized modalities of use)
 with exact medical indications (if applicable):
Name of disease or condition, clinical form, stage, severity, symptoms or aspects to be treated/
managed/ diagnosed, target patient population, target user group. Intended application of the device.
 Contraindications; warnings/precautions
Reference to technical documentation

3.2.6 Device claims

Claims in alignment with available promotional materials
 Claims on clinical performance and clinical safety foreseen by the manufacturer.
Reference to technical documentation/other documents
 Reference

3.2.7 Status of the device

Current status of device
Whether the device is already CE marked or not
 Under Development
 Undergoing Initial CE Marking
 CE Marked
Is Device currently on market in Europe or any other countries? : Yes or No
 If yes, date of market introduction and total number of devices placed in market
Reference to technical documentation/other documents
 Reference

3.2.8 Device Change History

Comments on significant changes
Changes since the last report,
 Whether the device has been modified? Yes/No If yes provide details
 Identification of Device new models, size, Yes/No If yes provide details
accessiories, software etc?
 New Intended Purpose? Yes/No If yes provide details
 New Claims? Yes/No If yes provide details
 New Events? Yes/No If yes provide details

3.2.9 Identification of changes

Section Change
Reference to Short reason why new information has been introduced and what was modified.
section

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3.2.10 Other aspects

Other aspects of relevance
 Mention any other aspects with an impact on this clinical evaluation. If no other aspects need to be
considered, mark with n.a.

3.3 Current Clinical Evaluation Route of Conformity

The clinical evaluation route of conformity (ROC) was initially determined during the planning
stage (Stage 0) through the Clinical Evaluation Plan (CEP) and continuously evaluated through
the execution stage (Stage 1-3). The ROC is based on relevant scientific literature relating to the
safety, performance, design characteristics, and intended purpose of the subject device plates.
The route of conformity for each of the subject device plates will be through literature and
post-market activities, including post-market surveillance.

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4 CLINICAL BACKGROUND, CURRENT KNOWLEDGE, STATE OF THE ART

This section is intended to provide a summary of the clinical background and state of the art of the
clinical therapeutic area. A description of the general medical condition, available therapeutic options,
historical context, and summary of the advantages and disadvantages, and associated benefits and risks
of the various devices on the market should be included. The reason for the development and/or need
for the device may also be included. Other available similar competitor products on the market are
recommended to be included. A separate state of the art literature search or state of the art articles
obtained during annual CER literature searches are to be used to update/support/describe the state of
the art. Recommended subsections are provided below; these may be altered or others may be added
for the subject device(s) as appropriate.

4.1 Literature Search Methods

Comprehensive literature searches are conducted annually for the DEVICE/PRODUCT NAME AND
MODEL NUMBER (S) and capture state of the art information in addition to product-specific information;
the search timeframes are in alignment with the post-market surveillance reporting periods and details
of the search methods may be found in Section XX Data from Published Scientific Literature. Relevant
state of the art information from these searches is included in this section on an ongoing basis.

4.2 Clinical Background

This section is intended to include a description of the clinical condition to be treated and historical
information pertinent to understanding the treatment of the clinical condition.

4.3 Treatment Development

This section is intended to include the historical treatment developments over time and how current
technologies treatments developed.

4.4 Currently Available Treatment Options

This section should include the subject device(s) and current similar modalties/comparable device(s) on
the market to treat the clinical condition. Based on the periodic literature reviews, updates to this
section are recommended as new device(s) come to the market.

4.5 State of the Art Discussion

This section should address what is considered the generally accepted state of the art for treatment of
the clinical condition and the benefit/risk profiles of the various options. Discussion of how the subject
device(s) fit into the state of the art is to be included. Updates to this section are recommended as new
information is obtained.

4.6 Alternative Treatment Methods

This section should address alternative treatment methods for the clinical condition in addition to the
subject device and comparable devices on the market; e.g. historical methods, new modalities on the
market that may not be well-established, etc. Updates to this section are recommended as new
information is obtained.

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4.7 Conclusion
A conclusion regarding the state of the art and commonly accepted treatment modalities for the clinical
condition is recommended.

4.8 References
References cited in the clinical background/state of the art section may be included either as footnotes
within the section or within a subsection.

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5 SUBJECT DEVICE UNDER EVALUATION

5.1 Subject Device Description and Specifications

 In this section includes complete details of subject device.

5.1.1 Required and Adjunctive Devices and Accessories Not Included in CER Scope
 Include details of device accessories which are not included in CER Review or Updation Scope

5.1.2 Intended Purpose

 Includes details as per subject device IFU

5.1.3 Clinical Claims

 Includes details as per subject device IFU

5.1.4 Indications
 Includes details as per subject device IFU

5.1.5 Contraindications
 Includes details as per subject device IFU

5.1.6 Adverse Events / Side Effects

 Includes details as per subject device IFU

5.1.7 Warnings and Precautions

 Includes details as per subject device IFU

5.1.8 Device Lifetime / Duration of Use

 Includes details as per subject device IFU

5.1.9 Magnetic Resonance Imaging (MRI) Compatibility

 Includes details as per subject device IFU

5.1.10 Sterility
 Includes details of sterility testing of subject device

5.1.11 Materials and Biocompatibility

 Includes details of Biocompatibility testing of materials and device

5.1.12 Principles of Operation

 Includes details of device method of operation along with respective images or pictures

5.2 Type of evaluation

The clinical evaluation is based on:

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 Clinical investigations made on the device under assessment i.e. Subject Device
The clinical evaluation is performed in following stages:
 Identification of pertinent clinical data (Stage 1)
 Objective appraisal of each individual data set, in terms of its scientific validity, relevance and
weighting (Stage 2)
 A subsequent analysis of all the data sets (Stage 3), whereby conclusions are reached about:
 Compliance with Essential Requirements (including ER1, ER3, ER6) on performance and
safety of the device, including its benefit/risk profile
 The contents of information materials supplied by the manufacturer
 Residual risks and uncertainties or unanswered questions

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6 EQUIVALENCE

6.1 Equivalent Device Description

 Includes details of Equivalent Device available information along with relevant source.

6.2 Equivalence Table(Below mention tables can be modify as per subject device requirements)
6.2.1 Clinical Equivalence
Table-XX: Comparison of Clinical Characteristics
Subject Device: XX Equivalent Device: YY Potential Clinical
Impact of Differences
Clinical Parameters - Intended use: Equivalence means used for the same clinical condition (including when applicable similar
severity and stage of disease, same medical indication), for the same intended purpose, at the same site in the body, in similar
populations (including age, gender, anatomy, physiology); 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.).
Intended Purpose

Indications

Contraindications
Anatomic Areas of
Use
Patient Population
Duration of
Use/Device Lifetime
6.2.2 Technical Equivalence
Table-YY: Comparison of Technical Characteristics
Subject Device: XX Equivalent Device: YY Potential Technical
Impact of Differences
Technical parameters: Equivalence means used be of similar design; used under same conditions of use; have similar
specifications and properties; use similar deployment methods (if relevant); have similar principles of operation and critical
performance requirements.
Device Materials

Device Length

Device Diameter

Device Delivery
System
(If Applicable)
Application

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6.2.3 Biological Equivalence

Table-ZZ: Comparison of Biological Characteristics
Subject Device: XX Equivalent Device: YY Potential Technical
Impact of Differences
Biological parameters – Equivalence means use of same materials or substances in contact with the same human tissues or
body fluids.
Human Tissue or
Body Fluids in
Contact with the
Device
Patient Contact

6.3 Equivalence Rationale

As shown in Table XX, Table YY, and Table ZZ, there are some differences between the subject and
equivalent device. Therefore, in accordance with MDD Annex X and MEDDEV 2.7/1 Rev.4, a critical
analysis of clinical, technological, and biological equivalency was conducted.
6.3.1 Summary of Differences
Provide brief summary of Clinical, Technical and Biological differences of subject device and equivalent
device.

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7 DATA SOURCES - IDENTIFICATION AND APPRAISAL (STAGE 1, 2)

7.1 Data Appraisal Plan

Comprehensive methods were utilized to identify and appraise all data sources that are generated and
held by [Manufacturer Name] for the subject devices including evidence from Europe and other
countries. The appraisal of each data source is described below, with further details in subsequent
sections for each data source.

For all data sources, suitability and contribution were determined by assessing whether the data were
generated on the subject device or other devices considered representative. More weight was given to
data collected directly on the subject device. Where the data were collected on other devices, a
rationale was included as to why these data were considered representative. Where data were
considered off-label, the rationale for this determination was identified and the data stratified. Data
were only included if the reports contained sufficient information to be able to undertake a rationale
and objective assessment.

For nonclinical testing (Section XX), the test methods/study designs were assessed to ensure they were
considered representative of the intended use of the subject device and of the treatment population.
For clinical data from scientific literature (Section XX), the data were appraised using the Oxford Centre
for Evidence Based Medicine (OCEBM) Levels of Evidence. The level of evidence for each citation was
assessed and higher levels (randomized controlled clinical trials, for example) are given more weight
towards overall conclusions and assessment of safety and performance when compared against lower
level cohort or case reports. Nevertheless, even case reports reflect real-world usage of the subject
device. Follow-up times, population characteristics, and device usage (compared against intended use)
are all appraised and factor into the presentation and weight of the data.

While of lower quality (due to the availability of limited information), post-market surveillance data
(Section XX), including complaints and sales, vigilance, CAPA, Escalations, Field Actions, and Alerts; still
provides valuable information towards the assessment of safety for the subject devices and reflects real
world usage. While the follow-up times and clinical use of the devices relative to the intended purpose
cannot easily be ascertained, the data obtained are representative of the treated population and are of
sufficient quality to allow a rationale and objective assessment.

Risk management data (Section XX), including identified clinical risks, benefits, and information provided
to the user on residual risks are evaluated in comparison to the other data sources and the SOA to
determine the acceptability of the known side effects and benefit-risk ratio.

The following matrix identifies the data sources being used to support safety and / or performance of
the subject devices to substantiate the identified ERs.

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Table-XX: Data Source Contribution

Performance / Clinical Side-Effect Benefit-Risk Profile
Data Source Safety/Clinical Risks
Benefits Acceptability Acceptability
Non-Clinical
Bench-Top Data
Analytical Data
Complaints/Sales Data

Vigilance Data

CAPAs, Field Actions,

Escalations
Clinical
Published Clinical Data

7.1.1 Non-Clinical Data

7.1.1.1 Summary of Bench-Top Data [If applicable]

 In this section includes Device Bench-Top Testing Data [Put proper Table with relevant reference
documents]

7.1.1.2 Summary of Analytical Data [If applicable]

 In this section includes Device Bench-Top Testing Data [Put proper Table with relevant reference
documents]

7.1.1.3 Summary of Animal Testing Data [If applicable]

 In this section includes Device Analytical Data Testing Data [Put proper Table with relevant
reference documents]

7.1.1.4 Summary of Animal Testing Data [If applicable]

 In this section includes Device Animal Testing Data [Put proper Table with relevant reference
documents]

7.1.1.5 Summary of Biocompatibility Testing Data [If applicable]

 In this section includes Device Biocompatibility Testing Data [Put proper Table with relevant
reference documents]

7.1.1.6 Verification and Validation

 In this section includes Device Verification and Validation Testing Data [Put proper Table with
relevant reference documents]

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7.1.2 Clinical Data

7.1.2.1 Pre-Market Clinical Investigations[If Applicable]

7.1.2.2 Review of External Registry Data[If Applicable]

7.1.2.3 Review of Internal Registry Data[If Applicable]

7.1.2.4 Post-Market Clinical Follow-Up (PMCF) [If Applicable]

7.1.2.5 Post Market Proactive Clinical Data[If Applicable]

7.1.2.6 Literature Review Methods (Literature Protocol)

A. Literature Search Objective

The literature search identifies clinical data relevant to the device under evaluation and/or to the
equivalent device (if equivalence is claimed). This systematic search of scientific literature was carried
out with the following objectives:

 To demonstrate that the [Name of Subject Device] is safe and performs as intended by the legal
manufacturer.
 To identify scientific literature related to the performance, characteristics and safety profile of
[Equivalent Device], to which equivalence is being claimed in this CER.

B. Literature Process/Strategy
In [Search Date], a systematic search of the scientific literature was performed. Details of how the
search was conducted, the databases used, and the search strategy are described in below Table-XX.

Table-XX: Literature Process/Strategy

Date of search request
Name of person(s) undertaking the literature search:
Period covered by search:
Literature sources used to identify data:
Scientific databases – bibliographic (e.g., MEDLINE, EMBASE,
NCBI PubMed)
Specialized databases (e.g., MEDION)
Systematic review databases (e.g., Cochrane Collaboration)
Clinical trial registers (e.g., CENTRAL)
Adverse event report databases (e.g., MAUDE, IRIS, DAEN,
BfArM, MDSR)
Language Restriction
Database search details
Search terms (key words, indexing headings) and their .

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relationships
Medium used (e.g. online, CD-ROM (including publication Online
date and edition))

C. Literature Selection criteria

The types of studies that are relevant to these objectives were specified in the inclusion and exclusion
criteria for the literature search:
 Inclusion criteria:
1. Literature provides data on performance, risk and/or safety relevant to subject device or
equivalent device.
2. Literature provides data relevant for the clinical evaluation of the subject device
3. Literature provides data on similar devices used in way similar to indications for use of the
subject device.
4. Literature contains insufficient information to undertake a scientific analysis about device
performance (due to poor trial design or inadequate analysis) but provides safety information.
 Exclusion criteria:
1. Literature describes technical or non-clinical study results only, including animal or cadaver
studies.
2. Literature contains unsubstantiated opinions.
3. Literature contains data on similar device not used according to indications for use.
4. Literature contains insufficient information to undertake a scientific analysis about device
performance. Literature whose full text is not available.
5. Full text of paper is available only in a language for which an English translation is not readily
available.

D. Relevance of Data/Literature Selection Process [Literature’s Level of Evidence]

The relevance of data and the extent to which the scientific articles related to the device in question and
the other objectives of this search are shown and discussed. The appraisal criteria are given in Tables XX
and YY. The criteria were applied to each clinical study in sequence and weightage was assigned for each
dataset accordingly. To assess the clinical data contribution criteria, the data sets were sorted according
to the source type and then systematically considered for the aspects that are most likely to impact on
the interpretation of the results (Table ZZ). It facilitated scope to determine what types of issues are
most important in relation to the nature, history and intended clinical application of the device. The
criteria listed below are based around the sorts of issues that could be considered for devices of higher
risk, such as characteristics of the sample, methods of assessing the outcomes, the completeness and
duration of follow-up, as well as the statistical and clinical significance of any results.
Table XX: Appraisal Criteria for Suitability
Suitability Criteria Description Grading System Acceptance
Appropriate device Were the data generated from the device D1 Actual device Yes
in question? Yes, if equivalence is
D2 Equivalent device
claimed
D3 Different device No
Appropriate device Was the device used for the same A1 Same use Yes

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application intended use (e.g., methods of A2 Minor deviation Yes
deployment, application, etc.)?
A3 Major deviation No
Appropriate patient Where the data generated from a patient P1 Applicable Yes
group group that is representative of the P2 Limited Yes
intended treatment population (e.g., age, No
sex, etc.) and clinical condition (i.e., P3 Different population
disease, including state and severity)?
Acceptable report/ Do the reports or collations of data R1 High quality Yes
data collation contain sufficient information to be able R2 Minor deficiencies Yes
to undertake a rational and objective No
R3 Insufficient information
assessment?
Table-YY: Appraisal criteria for data
Data Contribution Criteria Description Grading System
Data source type Was the design of the study appropriate? T1 Yes

T2 No
Outcome measures Does the outcome measures reported reflect the intended O1 Yes
performance of the device?
O2 No
Follow up Is the duration of follow-up long enough to assess whether F1 Yes
duration of treatment effects and identify complications?
F2 No

Statistical significance Has a statistical analysis of the data been provided and is it S1 Yes
appropriate? S2 No
Clinical significance Was the magnitude of the treatment effect observed clinically C1 Yes
significant?
C2 No

Besides the abovementioned appraisal criteria, the evidence provided by each study needs to be
assessed, as well. According to the Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence
(OCEMB), when reviewing the evidence three questions regarding the intervention should be
considered:

1. Is there a real effect?

2. Is the size of the effect clinically important?
3. Is the evidence relevant to practice?
The level of evidence provides an overview of performance data and indicates the study design used by
the investigators to assess the effectiveness of an intervention. The level assigned to a study reflects the
degree to which bias has been eliminated by the study design. Table 4designates the levels of evidence
used to assess the references selected based on the inclusion criteria .
Table-ZZ: Level of Evidence by OCEBM guidelines
Level 1 Systematic meta-analysis of randomized controlled trials (RTC)

Level 2 Randomized controlled trials (RTCs)

Level 3 Non-Randomized pro/retrospective cohort follow up studies

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Level 4 Case series or case report, case-control or historically controlled studies

Level 5 Expert opinion/ mechanism-based reasoning/technical note

Level L Non-clinical publications and laboratory studies

7.1.2.7 Literature Review Results (Literature Report)

A. Search and Selection Results

To ensure that all applicable literature was captured, broad literature searches were performed by an
information specialist for the period of [DD-MMM-YYYY to DD-MMM-YYYY]. The search was first run in
[DD-MMM-YYYY] for the period of [DD-MMM-YYYY to DD-MMM-YYYY]. The search start date was based
on the market launch of the equivalent comparator, [Name of Equivalent Device].

The search databases EMBASE and MEDLINE via OVID, and PubMed were searched, and the results were
imported into an internal literature management system (QUOSA/OR ANY OTHER IF APPLICABLE). The
full text, abstract, key words and title were then searched by the subject device and equivalent
comparator brand names. The Literature Search Report with detailed search queries, as well as the
included and excluded references with corresponding exclusion rationale, is provided in the appendices.
In the initial search, out of the final [No. of Literatures] possible results, [No. of Literatures] articles were
included and [No. of Literatures] were excluded due to the reasons presented in [

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Figure ].

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Figure XX: Search and Selection Flow Chart [Chart could be modify as per resource and available system]

Records identified through database searching (OVID via EMBASE, MEDLINE and PubMed) and
transferred to QUOSA or any other Literature management System (n = XXXX)
Identification

Records after QUOSA filter and

deduplication
(n = XXX)
Records excluded with reasons (n = XXX)
 Foreign Language (n = AA)
 Duplicates (n = BB)
 Review or Technical Article: (n = CC)
 No Clinical Data on Subject Device or equivalent
Screening

Records assessed for inclusion at comparator (n = DD)

First Level Screening  Mixed Cohort: (n = EE)
(n = XXX)  No safety or performance outcomes: (n = FF)

Records assessed for

inclusion at Second Level Records excluded with reasons (n = XX)
Screening (n = XXX)  Duplicate (n = X)
 No clinical data on subject device or equivalent
comparator (n = Y)

Included

No safety or performance outcomes (n = Z)

Included Studies (n = XXX)

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B. Study Population Characteristics

In this section provide proper summary of included literatures analysis where includes below mention
points.
a. Age
b. Study Design
c. Gender
d. Device Use and Indications
e. Geographical Location
f. Follow-Up Time

C. Performance Results
 In this section provide device performance description and in-depth analysis from included
literature (Includes Subject Device Completed Clinical Studies and Equivalent Device published
articles).

D. Safety Results
 In this section provide device safety description and in-depth analysis from included literature
(Includes Subject Device Completed Clinical Studies and Equivalent Device published articles).

7.1.3 Literature Review Conclusions

 In this section summarize overall conclusions of Literature review and analysis.

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8 POST-MARKET EXPERIENCE AND SURVEILLANCE (PMS)

Post Market Surveillance (PMS) process for the subject device is conducted under Post-Market
Surveillance Plan. In accordance with this procedure, the methods should obtain relevant and new
production and post-production information to evaluate any potential early warning signs of design and
quality problems, emerging issues or safety signals, and to assign action items as necessary throughout
the lifetime of the subject device. The PMS data for [NAMEOF SUBJECT DEVICE]includes internal,
external, and market-based sources of active data analysis as defined in PMS plan. PMS data has been
provided from [DD-MMM-YYYY to DD-MMM-YYYY] as extracted from the PMS Reports.

8.1 Complaint and Vigilance Data

8.1.1 Overall Complaints/ Sales Data [IF Applicable]

 In this section provide summary of subject device complaints and sales data information. This is
applicable for CER update and review for well-established and CE Marked device. If device is
under initial marking of CE this section should not be applicable.

8.1.2 Overview of Complaint Rate

 In this section provide summary of complaints rate followed by year with graphical
presentation.

8.1.3 Complaint Monitoring

 In this section provide brief summary of complaint monitoring system.

8.1.4 Complaints Data by Category

 In this section provide summary of complaints data by categories wise.

8.1.5 Analysis of the Top 4 Product Experience Codes

 In this section provide summary of top 4 reported complaints throughout the PMS.

8.2 Overall Complaint Analysis Conclusions

 In this section provide summary of overall complaints analysis conclusions.

8.3 External Vigilance Data or Adverse Event Databases

The adverse events related to subject device searched from online adverse events databases to retrieve
information related to safety. The following safety alert and/or recall databases were searched using the
search term “[NAME OF SUBJECT DEVICE AND EQUIVALENCE DEVICE]” and the results are summarized
in following tables.
Following adverse event databases were selected to provide broad coverage of the major adverse event
reporting databases.
A. Database of Adverse events Notification (DAEN)
B. MHRA Medical Device Alerts
C. BfArM Field Corrective Actions
D. Medical Device Safety Report (MDSR)

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E. MAUDE - Manufacturer and User Facility Device Experience

A. Database of Adverse Event Notifications (DAEN)
Source : http://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx
Search date: DD-MMM-YYYY
Date Range: DD-MMM-YYYY TO DD-MMM-YYYY
Search Strategy
DAEN (medical devices) can be searched for adverse events that have been reported in Australia
since 1 July 2012 TO [DD-MMM-YYYY]. The outline of search details is provided in Table XX.
Table XX: Search Conducted in the DAEN Database
Sr. # Search Term Result obtained Adverse event reported

1 NAME OF SUBJECT DEVICE 00 00

2 NAME OF EQUIVALENT DEIVE 00 00

B. MHRA Medical Device Alerts

Source:www.gov.uk/drug-device-alerts
Search date: DD-MMM-YYYY
Date Range: DD-MMM-YYYY TO DD-MMM-YYYY
Filter Activated: Medical device alert
Table XX: Search Conducted in the MHRA Medical Device Alerts Database
Sr. # Search Term Result obtained Adverse event reported

1 NAME OF SUBJECT DEVICE 00 00

2 NAME OF EQUIVALENT DEIVE 00 00

C. Federal Institute for Drugs and Medical Devices (BfArM) Field Corrective Actions
Source:
http://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html?nn
=4527724
Search date: DD-MMM-YYYY
Date Range: DD-MMM-YYYY TO DD-MMM-YYYY
Table XX: Search Conducted in the BfArM Field Corrective Actions Database
Sr. # Search Term Result obtained Adverse event reported

1 NAME OF SUBJECT DEVICE 00 00

2 NAME OF EQUIVALENT DEIVE 00 00

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D. Medical device safety reports (MDSR)

Source : http://www.mdsr.ecri.org/
Search date: DD-MMM-YYYY
Date Range: DD-MMM-YYYY TO DD-MMM-YYYY
Table XX: Search Conducted in the MDSR Database
Sr. # Search Term Result obtained Adverse event reported

1 NAME OF SUBJECT DEVICE 00 00

2 NAME OF EQUIVALENT DEIVE 00 00

E. MAUDE - Manufacturer and User Facility Device Experience

Source : https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm
Search date: DD-MMM-YYYY
Date Range: DD-MMM-YYYY TO DD-MMM-YYYY
Table XX: Search Conducted in the MAUDE Database
Sr. # Search Term Result obtained Adverse event reported

1 NAME OF SUBJECT DEVICE 00 00

2 NAME OF EQUIVALENT DEIVE 00 00

8.3.1 External Vigilance Data or Adverse Events Databases Results Summary

 In this section summarize all external vigilance databases searched results.

8.4 Post Market Surveillance Report Conclusion

 In this section provide overall conclusions of PMS data.

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9 BENEFIT / RISK ANALYSIS

9.1 Clinical Benefits / Performance Analysis

 Clinical benefits include any claims about clinical safety and performance outcomes. Clinical
safety and performance outcomes include the ability of the subject device to achieve its
intended purpose as claimed. Moreover provide performance outcomes summary from
literature review report.

9.2 Clinical Risks / Safety Analysis

9.2.1 Patient Harms (from Risk Management Documentation)

 In this section provide summary of Risk or potential harms which are presented in Risk
management documentation

9.2.2 Risks Identified in the Clinical Data

 In this section provide summary of Risk identified during literature review, PMS and from
conducted clinical studies.

9.3 Benefit-Risk Profile Acceptability

 In this section provide summary of Benefits and Risk profile acceptability on subject device.

9.4 Requirement for Post Market Clinical Follow-up (PMCF)

In accordance with the Directives, the clinical evaluation and the clinical evaluation report will be
actively updated with data obtained from post-market surveillance. [NAME OF MANUFACTURER]
maintains a PMS system which will routinely monitor the clinical performance and clinical safety of the
[NAME OF SUBJECT DEVICE] as part of its quality system. Any new, clinically-significant data from safety
reports, published literature, device registries, PMCF studies, and other sources will be continually
evaluated with respect to the benefit/risk profile, adverse events (whether previously known or newly
emerged), and risk mitigation activities. The PMS data will be incorporated in the clinical evaluation
process in a timely manner. Collectively, sufficient clinical data exists to support the safety and
performance of the [NAME OF SUBJECT DEVICE] in accordance with its intended purpose. [NAME OF
MANUFACTURER] has design PMCF studies to continually evaluate the long term performance and
safety of subject device. Detailed PMCF plan is provided in Annexure XXX.

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10 CONCLUSION
 In this section provide overall conclusion of CER review/updates.

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11 CER FREQUENCY
 In this section provide CER next evaluation or review details based upon subject device risk
classification.

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12 APPENDICES

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13 ABBREVIATIONS

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14 QUALIFICATION OF THE RESPONSIBLE EVALUATORS (INCLUDING CV)

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15 REFERENCES

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16 CER SIGNATURE AND DATE

This is a sample of a Clinical Evaluation Report for

informational purposes only and is intended as a guidance
document for medical device companies.
View freelance Clinical Evaluation Report writers
Connect with Girish Hirpara

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