Report on existing literature & literature gap search

Clinical evaluation template

Report on existing literature & literature gap search for medical device clinical evaluation

Use this editable Report on existing literature & literature gap search to structure clinical evidence, justify safety and performance conclusions, and keep your MDR/IVDR clinical evaluation documentation audit-ready.

Structure clinical evidenceCollect, appraise and analyse data with a repeatable methodology.

Align with MDCG 2020-6Rank and weight clinical data according to EU guidance.

Support notified-body reviewTrace decisions from evidence to GSPR conclusions.

Best for: clinical evaluation planning, CER/CEP/SSCP preparation, PMCF evidence review and literature appraisal.
Includes: editable sections aligned with MDR Annex XIV, MDCG 2020-6 and relevant MEDDEV guidance.
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At Lexqara, we connect clinical documentation, PMS activities and regulatory strategy so manufacturers can build defensible clinical evidence packages. Explore the Resource Center, review our Clinical Evaluation Services, or consult MDCG 2020-6 for the clinical evidence hierarchy.

Description:
This Existing Literature & Literature Gap Search Report documents the re-screening of existing citations and, when needed, a literature gap search to align evidence coverage for SoA and S&P AC over a defined period.

Confirm the report is performed per the referenced protocol and record any deviations with impact justification.
Define separate search periods for SoA and S&P AC, with justification for appropriateness.
Justify relevance of each existing literature search reports used for re-screening.
Re-screen existing citations against the current inclusion/exclusion criteria.
Decide and document the need for gap search when existing searches do not align with the required end date.
Apply protocol-based inclusion/exclusion criteria and document Level-1/Level-2 screening decisions.
Summarize screening outputs with reasons for exclusion and maintain a list of retained citations.

This template is used when prior literature search reports already exist, but you need to confirm their ongoing suitability for your device and fill time-based evidence gaps. It supports systematic re-screening and targeted “gap searches” so your SoA and S&P acceptance criteria evidence remains current and traceable.

Key requirements covered include objective-based screening and transparent gap rationale. A literature gap search extends a previously executed strategy to cover missing dates; it matters because it prevents undocumented evidence gaps. S&P AC means safety and performance acceptance criteria inputs; it matters because it anchors what “acceptable” looks like for comparable devices and alternatives.

At Lexqara, we help you standardise evidence continuity across CER updates by aligning protocols, screening rules, and gap search triggers—supporting clinical documentation, PMS, regulatory submission, and audit readiness. Explore our Resource Center [https://lexqara.com/resource-center/] and Clinical Activities [https://lexqara.com/service/clinical-activities/]. For institutional guidance, use MEDDEV 2.7/1 rev.4 [https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/]. Download the template and request a short gap assessment.

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Existing literature & literature gap search report

For

[Device Name]

Manufacturer Name: [Manufacturer name]

Document Number: XXXX

Revision: XXXX

Approval

Author

Approval
Name:	Date:
Title:	Signature:

Evaluator

Approval
Name:	Date:
Title:	Signature:
Approval
Name:	Date:
Title:	Signature:

Revision History

Table 1: History of revision

Revision	Date	Change History

2. Deviation to the protocol 6

3. Search period 6

4. Literature search 6

4.1. Existing literature search 6

4.2. Need of literature gap search 7

4.3. Inclusion and exclusion criteria 7

5. Summary of literature search results 8

5.1. Literature search queries for SOTA 8

5.1.1. Re-screening of existing literature for SOTA 8

5.1.2. Literature gap search queries for SOTA 9

5.1.3. Literature search results for SOTA 11

5.1.4. Reasons for exclusion from SOTA 11

5.1.5. Detailed literature search results for SOTA 11

5.2. Literature search queries for S&P AC 12

5.2.1. Re-screening of existing literature for S&P AC 12

5.2.2. Literature gap search queries for S&P AC 12

5.2.3. Literature search results for S&P AC 15

5.2.4. Reasons for exclusion from S&P AC 15

5.2.5. Detailed literature search results for S&P AC 16

6. List of retained citations 16

6.1. Citations for SOTA 16

6.2. Citations for S&P AC 16

Acronyms

AC	Acceptance criteria
S&P	Safety and performance
SOTA	State of the art

Objective

The existing literature & literature gap search report has been carried out according to the protocol [protocol number and revision]. A systematic approach has been applied to review the suitability of results for existing literature searches that appear relevant to the state of the art (SOTA) (Objective 1) and safety and performance acceptance criteria (S&P AC) (Objective 2) of [Device Name], hereafter named [device short name].

As other literature search reports relevant to the SOTA or S&P AC of [Device short name], are already issued, a re-screening of all citations retained from the existing literature search reports, has been carried out according to the inclusion/exclusion criteria described in Section 4.3. The citations that meet the inclusion criteria will be retained in this new literature search report applicable to [Device short name].

When a significant gap is observed between the end date of the existing literature searches and the end date of the period of search described in Section 3, a literature gap search is implemented according to the existing literature search protocol, to collect the new relevant literature articles.

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.

Search period

The SOTA 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)

The S&P AC 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)

Literature search

Existing literature search

The following table justifies the relevance of existing literature searches for the SOTA and S&P AC of [Device short name].

Table 2: Justification of existing literature search

Existing literature search	Justification (Justify why the literature search are relevant to the subject device used as intended)
Document Number and revision

Need of literature gap search

The following table describes the detail of search periods for the existing literature searches which have already been carried out and are relevant to the current search strategy for [device short name] as well as the need of literature gap search.

Table 3: Need of literature gap search (copy/paste from the protocol and remove the column “number of articles to be screened”)

Existing search	Objective			Existing Search Period		Gap search?	If yes, end date of search
Existing search	SOTA	AC	S&P	Start	End	Gap search?	If yes, end date of search
Document Number and revision	X			XX-MM-YYYY	XX-MM-YYYY	Yes/No	XX-MM-YYYY
Document Number and revision		X		XX-MM-YYYY	XX-MM-YYYY	Yes/No	XX-MM-YYYY

Include a justification when the literature gap searches have not been selected. It is recommended to systematically perform a gap search when the search periods are not aligned.

Inclusion and exclusion criteria

For the identification of literature articles relevant to the SOTA or S&P AC of [Device short name], the articles retained in the existing literature search reports as well as the results obtained from the implementation of literature gap searches, 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 SOTA (copy/paste from the protocol)

Code	Description
Inclusion criteria
I1	The article includes data that represent the SOTA of the medical condition treated/diagnosed by 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
E1	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, 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)
E2	Conference article, protocol, survey, position paper, case report, case series, XXX (to be adapted 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

Table 5: Inclusion/exclusion criteria for AC of S&P (copy/paste from the protocol)

Code	Description
Inclusion criteria
I1	The article includes on label data on safety and/or performance of similar devices and alternative treatments
IX
Exclusion criteria
E1	The article does not include safety and/or performance data on similar devices and alternative treatments
E2	The article includes off label data on safety and/or performance of similar devices and alternative treatments
E3	When multiple medical conditions are treated/diagnosed or multiple devices are used during the same study, data are not stratified in respect to similar devices / alternative treatments or the medical condition treated/diagnosed by similar devices / alternative treatments.
E4	Conference article, protocol, survey, position paper, case report, case series, reviews, non-controlled trial, non-randomized trial (to be adapted depending on the quality and quantity of expected results)
E5	Not in English
E6	Not in humans
E7	Article outside the period of search
E8	Duplicated reference
E9	Full text not accessible

Summary of literature search results

The literature search has been implemented according to the protocol described in Section 1 to:

detect the published articles related to the SOTA of the medical condition treated/diagnosed by [device short name],
detect the published articles related to devices similar to the subject device as well as alternative treatments, and bring clinical evidence for the definition of S&P AC that will be used for the demonstration of S&P of [device short name].

Literature search queries for SOTA

Re-screening of existing literature for SOTA

To confirm the suitability of literature articles retained in the existing literature search reports, a re-screening of all citations has been carried out according to the inclusion/exclusion criteria described in Section 4.3. The citations that met the inclusion criteria have been retained in this new literature search report as identified Section 6.1.

The following table describes the details of existing literature search reports including the number of articles that has been re-screened.

Table 6: Articles to be re-screened for SOTA (content of the table is part of the clinical data search protocol)

Existing search	Existing search period		Number of articles screened
Existing search	Start	End	Number of articles screened
Document Number and revision	XX-MM-YYYY	XX-MM-YYYY	XX

Literature gap search queries for SOTA

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 literature search queries updated to extend the period of search, that have been used for the identification of literature articles relevant to the SOTA of [Device short name].

Use the same queries as in the existing report and adapt the search period. For any other change a justification is necessary.

Table 7: Search queries for SOTA (table adapted from the protocol (removal of strategy column))

Literature database	Detailed limitations	Detailed query
Embase	EBM: Guidelines/de, Systematic review, Meta-analysis Date: Publication years from YYYY to YYYY Quick limits: Humans Only in English Publication types: Article


PubMed	Publication type: Practice Guidelines Meta analysis Systematic review Date – publication: YYYY/MM/DD to YYYY/MM/DD Language: English Filter: Humans


		All Text:
		All Text:
NICE	Filter: Type: Guidance Last updated: Last 3 years

Literature search results for SOTA

The following table describes the total number of articles collected in Sections 5.1.1 and 5.1.2 as well as the results of screening process.

Table 8: Search results for SOTA

Existing Search & Literature database	Query	Number of results	Total number of results without duplicate	Total number of results	Level 1 screening		Level 2 screening
Existing Search & Literature database	Query	Number of results	Total number of results without duplicate	Total number of results	Number of exclusions	Number included	Number of exclusions	Number included
Document Number and revision	–
Embase


PubMed


NICE

Reasons for exclusion from SOTA

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

Table 9: Summary of reasons for inclusion/exclusion for SOTA

TOTAL number of results	Level 1 screening		Level 2 screening
TOTAL number of results	Reasons for inclusion/exclusion	Number of results	Reasons for inclusion/exclusion	Number of results
	E1		E1
	E2		E2
	E3		E3
	E4		E4
	E5		E5
	E6		E6
	E7		E7
	I1		I1
	I2		I2
	I3		I3

Detailed literature search results for SOTA

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

Table 10: Justification for inclusion/exclusion for SOTA

#	Citations	Screening
#	Citations	LVL 1	LVL 2

Literature search queries for S&P AC

Re-screening of existing literature for S&P AC

The following table describes the details of existing literature search reports including the number of articles that has been re-screened.

Table 11: Articles to be re-screened for S&P AC (content of the table is part of the clinical data search protocol)

Existing search	Existing search period		Number of articles screened
Existing search	Start	End	Number of articles screened
Document Number and revision	XX-MM-YYYY	XX-MM-YYYY	XX

Literature gap search queries for S&P AC

The literature search has been carried out by: John Doe

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

Use the same queries as in the existing report and adapt the search period. For any other change a justification is necessary.

Table 12: Search queries for S&P AC (table adapted from the protocol (removal of strategy column))

Literature database	Detailed limitations	Detailed query
Embase	EBM: Randomized controlled trial, Controlled clinical trial, Systematic review, Meta-analysis Date: Publication years from YYYY to YYYY Quick limits: Humans Only in English Publication types: Article


PubMed	Publication type: Comparative study Controlled clinical trial Meta analysis Randomized controlled trial Systematic review Date – publication: YYYY/MM/DD to YYYY/MM/DD Language: English Filter: Humans


Cochrane Library	Content type: Cochrane Review Trials Cochrane Library publication date: Between Month YYYY and Month YYYY Search word variations: activated	All Text:
		All Text:
		All Text:
EU Clinical Trials Register	Select Date Range: YYYY-MM-DD to YYYY-MM-DD Results Status: Trials with results


Clinicaltrials.gov	Study status: All studies Study type: Interventional Observational Study results: with results Date Range: Last update posted: From MM/DD/YYYY to MM/DD/YYYY	Other terms:
		Other terms:
		Other terms:

Literature search results for S&P AC

The following table describes the total number of articles collected in Sections 5.2.1 and 5.2.2 as well as the results of screening process.

Table 13: Search results for S&P AC

Existing Search & Literature database	Query	Number of results	Total number of results without duplicate	Total number of results	Level 1 screening		Level 2 screening
Existing Search & Literature database	Query	Number of results	Total number of results without duplicate	Total number of results	Number of exclusions	Number included	Number of exclusions	Number included
Document Number and revision	–
Embase


PubMed


Cochrane Library


EU Clinical Trials Register


Clinicaltrials.gov

Reasons for exclusion from S&P AC

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

Table 14: Summary of reasons for inclusion/exclusion for S&P AC

TOTAL number of results	Level 1 screening		Level 2 screening
TOTAL number of results	Reasons for inclusion/exclusion	Number of results	Reasons for inclusion/exclusion	Number of results
	E1		E1
	E2		E2
	E3		E3
	E4		E4
	E5		E5
	E6		E6
	E7		E7
	E8		E8
	E9		E9
	I1		I1

Detailed literature search results for S&P AC

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

Table 15: Justification for inclusion/exclusion for S&P AC

#	Citations	Screening
#	Citations	LVL 1	LVL 2

List of retained citations

Citations for SOTA

Citations for S&P AC

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SKU LEX-FORM-EU-009 rev.1 Category Clinical Documents

Report on existing literature & literature gap search