Literature Search Report for SoA

For

[Device Name]

Manufacturer Name: [Manufacturer name]

Document Number: XXXX

Revision: XXXX

Form Number: LEX-FORM-EU-006 rev.1 Confidential

 Literature Search Report for SoA [Doc Number] rev.Y

Approval

Author

Approval
Name: Date:

Title: Signature:

Evaluator

Approval
Name: Date:

Title: Signature:

Approval
Name: Date:

Title: Signature:

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Revision History

Table 1: History of revision

Revision Date Change History

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Table of Content

Contents
Approval...................................................................................................................................................................................................... 2
Revision History...................................................................................................................................................................................... 3
Table of Content....................................................................................................................................................................................... 4
Acronyms.................................................................................................................................................................................................... 5
1. Objective............................................................................................................................................................................................ 6
2. Deviation to the protocol........................................................................................................................................................... 6
3. Search period.................................................................................................................................................................................. 6
4. Search databases........................................................................................................................................................................... 6
4.1. Literature search database..............................................................................................................................................6
4.2. Clinical trials database...................................................................................................................................................... 6
4.3. Clinical evidence from the previous CER..................................................................................................................6
4.4. Inclusion and exclusion criteria....................................................................................................................................7
5. Summary of literature search results...................................................................................................................................7
5.1. Introduction........................................................................................................................................................................... 7
5.2. Overall Search limitations................................................................................................................................................7
5.3. Search queries....................................................................................................................................................................... 8
5.4. Search results..................................................................................................................................................................... 10
5.5. Reasons for exclusion..................................................................................................................................................... 10
6. Detailed literature search results........................................................................................................................................10
7. List of retained citations for SoA..........................................................................................................................................11

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Acronyms

CER Clinical evaluation report

EBM Evidence based medicine
EEA European economic area
EU European union
LVL Level
MEDDEV Medical Devices Documents
N/A Not applicable
SoA State of the art

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1. Objective
The literature search report has been carried out according to the protocol [protocol number and
revision]. A systematic approach has been applied to collect clinical literature articles that support the
SoA of [Device Name], hereafter named [device short name] (Objective 1).

2. Deviation to the protocol

No deviation to the protocol described in Section 1.
All deviations need to be justified for their impact on the results.

3. Search period
The SoA literature search report is defined to cover the period from [start date (DD Month YYYY)] to [end
date (DD Month YYYY)].
As described in the protocol indicated in Section 1, Include a justification how the period selected is
appropriate (copy/paste justification from the protocol)

4. Search databases

4.1. Literature search database

The following literature databases have been selected to collect the published literature articles that
support the SoA of [device short name].

Table 2: Search databases for published literature

Literature Database Justification (copy/paste the justification from the protocol)

Embase is a recognized database for literature described in Section A4 of
MEDDEV 2.7/1 rev.4.
Embase
Embase will be used as a primary medical literature database for the collection of
clinical data using dedicated search terms.
Pubmed is a recognized database for literature described in Section A4 of
MEDDEV 2.7/1 rev.4.
Pubmed
Pubmed will be used as a primary medical literature database for the collection
of clinical data using dedicated search terms
NICE means National Institute for Health and Care Excellence and has the
purpose to help healthcare professionals via guidance documents,
NICE recommendations.
NICE is used as secondary database for the collection of clinical data missed in
the primary databases to establish the SoA.

4.2. Clinical trials database

No clinical trials database has been selected for the collection of SoA clinical evidence.

4.3. Clinical evidence from the previous CER

To be removed if not applicable

Literature articles included in the previous clinical evaluation report (CER) will be screened against the
inclusion/exclusion criteria to verify their continuous suitability.

Table 3: Searches in previous CER

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Previous CER Number of articles to be screened

Document Number and revision

4.4. Inclusion and exclusion criteria

For the identification of relevant literature articles, the results from the literature search implementation
have been reviewed for inclusion based on the titles and abstracts (Level-1 screening) and the full articles
(Level-2 screening). The decision to retain each article has been defined based on the inclusion/exclusion
criteria described below.

Table 4: Inclusion/exclusion criteria for SoA (copy/paste from the protocol)

Code Description
Inclusion criteria
The article includes data that represent the SoA of the medical condition treated/diagnosed by
I1
the subject device
I2 The article includes data on benefits/risks, advantages/disadvantages of alternative treatments
I3 The article includes data on benefits/risks, advantages/disadvantages of similar devices
IX
Exclusion criteria
The article does not include data:
- on the current knowledge/state of the art relevant to the medical condition
treated/diagnosed by the subject device (e.g., clinical background, clinical condition,
E1 prevalence)
- on the current knowledge/state of the art relevant to similar devices and medical
alternatives available for the target population and medical condition (e.g.,
benefits/risks/advantages/disadvantages of similar devices and alternative treatments)
Conference article, protocol, survey, position paper, case report, case series, XXX (to be adapted
E2
depending on the quality and quantity of expected results)
E3 Not in English
E4 Not in humans
E5 Article outside the period of search
E6 Duplicated reference
E7 Full text not accessible
EX

5. Summary of literature search results

5.1. Introduction
The literature search has been implemented according to the protocol described in Section 1 to detect
the published articles related to the SoA of the medical condition treated/diagnosed by [device short
name].

5.2. Overall Search limitations

The search limitations, such as types of articles, language, etc. differ from a database to another. Hence,
this section describes the overall search limitation strategy that has been applied in the literature search.

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Table 5: Overall search limitations (table adapted from the protocol)

Type of
Type of search Objective Description
limitation
Search period: See Section 3
Literature Article type: guidelines/meta-analysis/systematic review
SoA
search Language: English
Population: Humans

5.3. Search queries

The literature search has been carried out by: John Doe

The literature search has been implemented on: DD/MM/YYYY

The following table describes the search queries that have been used for the identification of literature
articles relevant to the SoA of the medical condition treated/diagnosed by [Device short name].

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Table 6: Search queries for SoA (table adapted from the protocol (removal of strategy column))

The queries need to be as detailed as possible with all limitations, start/end dates of search, exact keywords, connectors, etc. to be
reproducible later by another author and to be modified easily for an update

Literature
Detailed limitations # Detailed query
database
EBM: 1.
 Guidelines/de, 2.
 Systematic review,
 Meta-analysis
Date: Publication years
Embase
from YYYY to YYYY
3.
Quick limits:
 Humans,
 Only in English
Publication types: Article
Publication type: 4.
 Practice Guidelines 5.
 Meta analysis 6.
 Systematic review 7. All Text:
Date – publication:
YYYY/MM/DD to
Pubmed YYYY/MM/DD
Language: English
Filter: Humans 8. All Text:

9.
Filter:
10.
 Type : Guidance
NICE 11.
 Last updated : Last 3
12.
years
13.
Previous CER:
N/A – all articles included in the previous CER will be re-screened to confirm their suitability.
XXX rev.1

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5.4. Search results

The following table describes the total number of articles collected after the implementation of each
literature search query as well as the number of excluded/included articles after level-1 and level-2
screening processes.

Table 7: Search results

Total Level-1 screening Level-2 screening

Total
Numbe number
Literature numbe
Query r of of results Number of Number Number of Number
database r of
results without exclusions included exclusions included
results
duplicate
1.
Embase 2.
3.
4.
Pubmed 5.
6.
7.
NICE 8.
9.
Previous CER:
10.
XXX rev.1

5.5. Reasons for exclusion

The following table describes the summary of reasons for inclusion/exclusion for all articles collected via
the literature search strategy implemented.

Table 8: Summary of reasons for inclusion/exclusion

TOTAL Level-1 screening Level-2 screening

number of Reasons for Reasons for
Number of results Number of results
results inclusion/exclusion inclusion/exclusion
E1 E1
E2 E2
E3 E3
E4 E4
E5 E5
E6 E6
E7 E7
E8 E8
I1 I1
I2 I2

6. Detailed literature search results

The following table describes the reasons for inclusion/exclusion of all individual articles collected via
the literature search strategy implemented.

Table 9: Justification for inclusion/exclusion

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Screening
# Citations
LVL-1 LVL-2
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.

7. List of retained citations for SoA

1. XXX
2. XXX

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