Clinical data search protocol

Clinical evaluation template

Clinical data search protocol for medical device clinical evaluation

Use this editable Clinical data search protocol 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 Clinical Data Search Protocol defines a systematic approach for collecting clinical evidence to support SoA, AC, and S&P objectives.
• Define objectives for state of the art (SoA), acceptance criteria (AC), and safety & performance (S&P) evidence.
• Specify justified search periods per objective (SoA, AC, S&P).
• Document exact queries with connectors, limits, and date ranges for reproducibility.
• Apply PICO-based research questions and reproducible search queries.
• Use defined search databases (e.g., Embase, PubMed, Cochrane, trials registries).
• Set global search limitations (article type, language, humans) per objective.
• Remove duplicates within and across databases using defined rules.
• Perform Level-1/Level-2 screening with documented inclusion/exclusion criteria.
• Include vigilance/recall searches (e.g., FDA MAUDE/recalls) and document outcomes.
• Produce search reports to feed CER/PMCF and related deliverabl

This protocol is used to plan and justify literature, vigilance, and recall searches so clinical evidence collection is consistent, reproducible, and aligned with MEDDEV 2.7/1 rev.4. It supports updates to clinical evaluation and post-market activities by defining what to search, where, and how results will be screened and recorded.

Key requirements covered include traceable search logic and defensible screening. PICO means structuring research questions by population, intervention, comparator, and outcomes to drive targeted queries; it matters because it prevents gaps and irrelevant hits. PRISMA is a reporting framework to summarize screening flow; it matters because it improves transparency of inclusion decisions.

At Lexqara, we help you operationalize this protocol into controlled templates, reviewer-ready search reports, and CER/PMCF evidence packages—covering clinical documentation, PMS, and regulatory submission support. Explore our Resource Center [https://lexqara.com/resource-center/] and our Regulatory Strategy service [https://lexqara.com/service/regulatory-strategy/]. For institutional guidance, see European Commission Guidance MEDDEVs [https://health.ec.europa.eu/document/download/c1a6aa0b-d8c8-498b-8ed4-9f3c6211896d_en]. Request a short gap assessment of your current search approach.

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Clinical Data Search Protocol

For

[Device Name]

Manufacturer Name: [Manufacturer name]

Document Number: XXXX

Revision: XXXX

Approval

Author Approval

Approval
Name:	Date:
Title:	Signature:

Evaluator Approval

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

Revision History

Table 1: History of revision

Revision	Date	Change History

Table of Content

3. Overall description of search methodology 6

3.1. Literature search methodology 6

3.2. Vigilance / Recall search methodology 7

3.3. Search databases 7

3.3.1. Literature search database 7

3.3.2. Clinical trials database 8

3.3.3. Vigilance/recall search database 8

3.3.4. Clinical evidence from the previous CER 10

3.4. Overall search limitations 11

3.5. Literature inclusion and exclusion criteria 11

3.6. Method to remove duplication of articles 13

4. Literature search strategy for SoA 13

4.1. Literature search terms for SoA 13

4.2. Literature search queries for SoA 13

5. Literature search strategy for AC 16

5.1. Literature search terms for AC 16

5.2. Literature search queries for AC 16

6. Literature search strategy for S&P 19

6.1. Literature search terms for S&P 19

6.2. Literature search queries for S&P 19

7. Other literature searches 22

8. Vigilance/recall search strategy 22

8.1. SoA search terms for vigilance/recall 22

8.2. AC search terms for vigilance/recall 23

8.3. S&P search terms for vigilance/recall 23

8.4. Vigilance / Recall search queries and results 24

9. Search reports 27

Acronyms

AC	Acceptance criteria
ANSM	Agence nationale de sécurité du médicament et des produits de santé
Bfarm	Bundesinstitut für arzneimittel und medizinprodukte
CER	Clinical evaluation report
DAEN	Database of adverse event notifications
EEA	European economic area
EU	European union
EUDAMED	European database on medical devices
FDA	Food and drug administration
FSCA	Field safety corrective action
MAUDE	Manufacturer and User Facility Device Experience
MHRA	Medicines and healthcare products regulatory agency
MEDDEV	Medical Devices Documents
N/A	Not applicable
NICE	National institute for health and care excellence
PICO	Populations, interventions, comparators, outcomes
PMCF	Post-market clinical follow-up
PRISMA	Preferred reporting items for systematic reviews and meta-analyses
SARA	System for australian recall actions
SoA	State of the art
S&P	Safety and performance
TPLC	Total product lifecycle
UK	United Kingdom
US	United States
WHO	World health organization

Objective

The protocol of literature, vigilance and recall search applies a systematic approach to collect clinical evidence:

To establish the state of the art (SoA) of the medical conditions treated/diagnosed by [Device Name] (hereafter named ([Device short name]) (Objective 1)
To define the acceptance criteria (AC) of safety and performance (S&P) based on the SoA (Objective 2)
To support the S&P of [Device short Name] (Objective 3)

Search period

The protocol of literature, vigilance and recall search covers the following period:

From [start date (DD Month YYYY)] to [end date (DD Month YYYY)] for the SoA

Include a justification how the period selected is appropriate

From [start date (DD Month YYYY)] to [end date (DD Month YYYY)] for the S&P AC

Include a justification how the period selected is appropriate

From [start date (DD Month YYYY)] to [end date (DD Month YYYY)] for the S&P of [Device short name]

Include a justification how the period selected is appropriate

Overall description of search methodology

Literature search methodology

A literature search will be implemented to detect the published and unpublished articles related to:

the current state of the art for the medical conditions treated/diagnosed by the subject device,
devices deemed similar to the subject device and/or when applicable, alternative treatments to establish the acceptable limits of safety and performance.
the subject or equivalent devices and bring clinical evidence for the demonstration of safety and performance,

The literature search methodology will be carried out in compliance with Section A5 of MEDDEV 2.7/1 rev.4. Research questions will be constructed using a PICO (Populations, Interventions, Comparators, Outcomes) process to justify the selection of relevant keywords (see Sections 4.1, 5.1, 6.1). In the literature databases described in Section 3.3, the search queries will be defined using the selected keywords in a way to match with the language of each database used. The queries will have to incorporate the relevant search limitations defined in Section 3.4 (e.g., article type, language, as applicable). The exact queries are defined in Sections 4.2, 5.2, 6.2 and the result of literature search implementation will be documented in the literature search report(s) as indicated in Section 9.

The result of literature search will be a list of articles that will be screened in two stages:

Level-1 screening is based on the titles and abstracts
Level-2 screening is based on the full articles

The screening process consists of the review of each collected article to confirm if it should be included or excluded based on the inclusion/exclusion criteria defined in Section 3.5. The justification for inclusion or exclusion at Level-1 and Level-2 screening will be documented in the literature search report(s) as indicated in Section 9.

The CER and/or post-market clinical follow-up (PMCF) evaluation report or other activities e.g., PSUR, Summary Report,… for the subject device using the literature search reports will include a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram to summarize the results of screening process.

The CER or PMCF evaluation report or other activities e.g., PSUR, Summary Report,… will summarize and analyze the relevant clinical data regarding the objectives listed in Section 1.

Vigilance / Recall search methodology

A vigilance / recall search will be implemented to detect the clinical risks (i.e., device problem, patient problems) related to:

devices deemed similar to the subject device and/or, alternative treatments when applicable to obtain additional clinical evidence for the establishment or the confirmation of the acceptable limits of safety and performance.
the subject or equivalent devices and bring additional clinical evidence for the demonstration of safety and performance.

The vigilance / recall search methodology will be carried out using an approach similar to the literature search methodology described in Section 3.1. Research questions will be constructed using a PICO process to justify the selection of relevant keywords (see Section 3.3). In the vigilance / recall databases described in Section 3.3, the search queries will be defined using the selected keywords in a way to match with the language of each database used. The queries will have to incorporate the relevant search limitations defined in Section 3.3 (e.g., search period). The exact queries are defined in Section 6.2 and the result of vigilance / recall search implementation will be documented in the vigilance / recall search report(s) as indicated in Section 9.

The result of vigilance / recall search will be a list of events that will be screened to determine if applicable to similar devices (or alternative treatments when applicable) or the subject/equivalent devices. The justification for inclusion or exclusion will be documented in the vigilance / recall search report(s) as indicated in Section 9.

The CER or PMCF evaluation report or other activities e.g., PSUR, Summary Report,… will analyze the clinical risks identified based on the events reported.

Search databases

Literature search database

The following literature databases will be used for the implementation of this search protocol.

Table 2: Search databases for published literature

Literature Database	Objectives			Justification
Literature Database	SoA	AC	S&P	Justification
Embase	X	X	X	Embase is a recognized database for literature as described in Section A4 of MEDDEV 2.7/1 rev.4. Embase will be used as a primary medical literature database for the collection of clinical data using dedicated search terms.
Pubmed	X	X	X	Pubmed is a recognized database for literature as described in Section A4 of MEDDEV 2.7/1 rev.4. Pubmed will be used as a primary medical literature database for the collection of clinical data using dedicated search terms
Cochrane Library		X	X	Cochrane Library includes a database of systematic reviews (Cochrane Reviews) in health care. Cochrane Library is used as secondary database for the collection of clinical data missed in the primary databases to determine the S&P acceptance criteria and support the S&P of the subject device.
NICE	X			NICE means National Institute for Health and Care Excellence and has the purpose to help healthcare professionals via guidance documents, recommendations. NICE is used as secondary database for the collection of clinical data missed in the primary databases to establish the SoA.
Google Scholar			X	Google scholar will be used to pre-screen the literature available for the subject device to evaluate the quantity and quality of clinical literature available. The pre-screening of clinical literature will not be documented. Google Scholar will also be used as secondary database for the collection of clinical data that will be used to support the safety and performance of the subject device when the results are poor via the primary databases. Hence, the use of Google Scholar is optional.

Clinical trials database

The following clinical trial databases will be used for the implementation of this search protocol.

Table 3: Search database for non-published literature

Clinical Trial Database	Objective			Justification
Clinical Trial Database	SoA	AC	S&P	Justification
EU Clinical Trials Register		X	X	The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA). This database enables to search for clinical trials in the EudraCT database (used by national medicines regulators for data related to clinical trial protocols) and World Health Organization (WHO’s) Registry Network (for which EU Clinical Trials Register is a primary registry.
Clinicaltrials.gov		X	X	Clinicaltrials.gov is the database of clinical trials conducted in US.

Vigilance/recall search database

The following vigilance/recall databases will be used for the implementation of this search protocol.

Table 4: Search database for vigilance and recall data

Vigilance / Recall database	Objective			Justification
Vigilance / Recall database	SoA	AC	S&P	Justification
FDA MAUDE		X	X	“MAUDE” is the database to report the adverse events occurred in US. Though the population involved and the procedure applied may differ as compared to the population and procedure in EU, this bias is not considered significant. [Device short name] and similar devices is/are sold in US, hence the database is deemed relevant to collect applicable clinical risks (device or patient problem) for the S&P and AC objectives.
FDA Medical Device Recalls		X	X	“FDA Medical Device Recalls” is the database to report recalls in US. Though the population involved and the procedure applied may differ as compared to the population and procedure in EU, this bias is not considered significant. [Device short name] and similar devices is/are sold in US, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives.
FDA TPLC		X		TPLC is a database that describes the types and quantity of significant adverse events and recalls reported in US for a specific product code or regulation number. As the database is not specific to the subject device, it is not used to support the S&P objective. However, the database is relevant to give an overview of clinical risks reported in US for devices with the same technology. Though the population involved and the procedure applied may differ as compared to the population and procedure in EU, this bias is not considered significant.
ANSM safety information		X	X	Database with limited value as the results are only in French. “ANSM safety information” is one of the EU databases for recalls, field safety notices, and ANSM safety alerts reported in France. [Device short name] and similar devices is/are sold in France, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives.
Bfarm Field Corrective Actions		X	X	Database with limited value as the period of search is not sufficiently detailed. “Bfarm Field Corrective Actions” is one of the EU databases for field safety corrective actions (e.g., recall, Field safety notice) reported in Germany. [Device short name] and similar devices is/are sold in Germany, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives.
MHRA Alerts, recalls and safety information: drugs and medical devices		X	X	“MHRA Alerts, recalls and safety information” is a database for field safety corrective actions reported in United Kingdom (UK). [Device short name] and similar devices is/are sold in UK, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives. UK is no longer in EU but the population and clinical practices are representative of those in EU. The bias is not considered significant.
SwissMedic – FSCA and recall		X	X	“SwissMedic – FSCA and recall” is a database for field safety corrective actions reported in Switzerland. [Device short name] and similar devices is/are sold in Switzerland, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives. Switzerland is not in EU but the population and clinical practices are representative of those in EU. The bias is not considered significant.
DAEN (Database of Adverse Event Notifications) – medical devices		X	X	“DAEN” and “SARA” are databases for reporting of adverse events and recalls in Australia. Though the population involved and the procedure applied may differ as compared to the population and procedure in EU, this bias is not considered significant. [Device short name] and similar devices is/are sold in Australia, hence the databases are deemed relevant to collect applicable clinical risks for the S&P and AC objectives.
SARA (System for Australian Recall Actions)		X	X
Canadian recalls and safety alerts (advanced search)		X	X	Database with limited value as the period of search is not sufficiently detailed. “Canadian Recalls and safety alerts” is the database to report recalls in Canada. Though the population involved and the procedure applied may differ as compared to the population and procedure in EU, this bias is not considered significant. [Device short name] and similar devices is/are sold in Canada, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives.
EUDAMED	N/A	N/A	N/A	The database is not currently available.

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 5: Searches in previous CER

Previous CER	Objective			Number of articles to be screened
Previous CER	SoA	AC	S&P	Number of articles to be screened
Document Number and revision	X
		X
			X

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 will be applied.

Table 7: Overall search limitations

Type of search	Objective	Type of limitations	Description
Literature search	SoA	Search period: Article type: Language: Population:	See Section 2 guidelines/meta-analysis/systematic review English Humans
	AC	Search period: Article type: Language: Population:	See Section 2 Controlled clinical Trials/meta-analysis/systematic review English Humans
	S&P	Search period: Article type: Language: Population:	See Section 2 Controlled clinical Trials/meta-analysis/systematic review English Humans
Vigilance/recall search	AC	Search period:	See Section 2
	SoA	N/A – no vigilance/recall search implemented for the SoA.
	S&P	Search period:	See Section 2

The exact queries, described in Sections 4.2, 5.2, 6.2 for the literature and Section 8.4 for the vigilance/recall, will indicate the exact limitations applied in each database.

Literature inclusion and exclusion criteria

For the identification of relevant literature articles, two levels of screening are applied as described in Section 3.1. The articles resulting from the literature search implementation are 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 is defined based on the inclusion/exclusion criteria respectively described below for the objectives of SoA, AC and S&P of the [device short name].

Table 8: Inclusion/exclusion criteria for SoA

Code	Description
Inclusion criteria
I1	The article includes data that represent the SoA 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 9: Inclusion/exclusion criteria for AC of S&P

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
EX

Table 10: Inclusion/exclusion criteria for S&P

Code	Description
Inclusion criteria
I1	The article includes on label data on safety and/or performance of the subject device
I2	The article includes off label data on safety and/or performance of the subject device
IX
Exclusion criteria
E1	The article does not include safety and/or performance data on the subject device
E2	When multiple medical conditions are treated/diagnosed or multiple devices are used during the same study, data are not stratified in respect to the subject device or the medical condition treated/diagnosed by subject device.
E3	Conference article, protocol, survey, position paper, reviews, non-controlled trial, non-randomized trial (to be adapted depending on the quality and quantity of expected results)
E4	Not in English
E5	Not in humans
E6	Article outside the period of search
E7	Duplicated reference
E8	Full text not accessible
EX

Method to remove duplication of articles

The method to remove the potential for duplication of data across multiple publications is performed in two stages:

When multiple queries are searched in the same database, a final query is implemented to combine all queries using the connector OR. This method is intended to remove all duplications of articles obtained from the same database. This process is repeated for each database.
The duplications of articles obtained from different databases is removed through a review of all obtained citations comparing primarily the title of each article and then the full citation. The article will be excluded using the appropriate exclusion criteria described in Section 3.5.

Literature search strategy for SoA

Literature search terms for SoA

Using a PICO approach, the following table describes the search terms that will be used for the collection of literature articles relevant to the SoA of [Device short name].

Table 11: PICO terms for SoA via literature

PICO	Description	Terms for literature search
Population	Describe the characteristics of the population	Indication: xxx xxx
Intervention	Describe all alternative interventions (i.e., procedures; approaches)	xxx xxx
Comparator	Describe all alternative treatments (i.e., alternative name)	xxx xxx
Outcomes	Describe the recognized endpoints for safety and performance	N/A – related keywords are not deemed required for the objective of search
Retained combination and justification
Retained combination of terms: Indication AND Intervention Indication AND Comparator XXX Justification: The combination of keywords needs to be considered sufficient to cover the complete SoA.

Literature search queries for SoA

Based on the combination of keywords selected via the PICO approach and using the appropriate search limitations, the literature search queries have been defined for each database selected. The following table describes the search queries that will be used for the identification of literature articles relevant to the SoA of [Device short name].

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

Table 12: Search queries for SoA

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

Pubmed	Indication AND Intervention	Publication type: Practice Guidelines Meta analysis Systematic review Date – publication: YYYY/MM/DD to YYYY/MM/DD Language: English Filter: Humans
	Indication AND Comparator

			All Text:
			All Text:
NICE	Indication AND Intervention	Filter: Type : Guidance Last updated : Last 3 years
	Indication AND Comparator



Previous CER: XXX rev.1	–	N/A – all articles included in the previous CER will be re-screened to confirm their suitability.

Literature search strategy for AC

Literature search terms for AC

Using a PICO approach, the following table describes the search terms that will be used for the collection of literature articles relevant to the AC of [Device short name].

Table 13: PICO terms for AC via literature

PICO	Description	Terms for literature search
Population	Describe the characteristics of the population (generally the same as for S&P)	Indication: Xxx xxx
Intervention	Describe the interventions for which the AC are defined (generally the same as the S&P)	xxx xxx
Comparator	List similar devices consistently with the TD List alternative approaches when necessary (i.e., when the AC cannot be defined based on similar devices only (e.g., breaking technology, too poor results with similar devices))	Similar devices: xxx xxx
Outcomes	Describe the recognized endpoints for safety and performance	xxx xxx
Retained combination and justification
Retained combination of terms: similar devices (i.e., manufacturer name AND device name) AND indication similar devices (i.e., manufacturer name AND device name) AND intervention similar devices (i.e., manufacturer name AND device name) AND outcomes Justification: The combination of keywords needs to be considered sufficient to define the AC of safety and performance. The subject device does not have specific novelty and several similar devices have a long history of use on the market. Hence, the primary keywords of search will be based on similar device names (including manufacturer name + device brand name). The secondary keywords are based on intervention, comparator and outcomes of the PICO process. The selected keywords are evaluated sufficient to cover the objective of AC.

Literature search queries for AC

Table 14: Search queries for AC of S&P

Literature database	Strategy	Detailed limitations	Detailed query
Embase	similar devices AND indication	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
	similar devices AND intervention
	similar devices AND outcomes
Pubmed	similar devices AND indication	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
	similar devices AND intervention
	similar devices AND outcomes
Cochrane Library	similar devices AND indication	Content type: Cochrane Review Trials Cochrane Library publication date: Between Month YYYY and Month YYYY Search word variations: activated	All Text:
	similar devices AND intervention		All Text:
	similar devices AND outcomes		All Text:
EU Clinical Trials Register	similar devices AND indication	Select Date Range: YYYY-MM-DD to YYYY-MM-DD Results Status: Trials with results
	similar devices AND intervention
	similar devices AND outcomes
Clinicaltrials.gov	similar devices AND indication	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:
	similar devices AND intervention		Other terms:
	similar devices AND outcomes		Other terms:
Previous CER: XXX rev.1	–	N/A – all articles included in the previous CER will be re-screened to confirm their suitability.

Literature search strategy for S&P

Literature search terms for S&P

Using a PICO approach, the following table describes the search terms that will be used for the collection of literature articles relevant to the S&P of [Device short name].

Table 15: PICO terms for S&P via literature

PICO	Description	Terms for literature search
Population	Describe the characteristics of the population	Indications: xxx xxx Age: adult pediatric
Intervention	Describe the interventions (i.e., procedure type, approach)	Device Name: xxx
Comparator	N/A – the searches for S&P are focused on the subject device
Outcomes	Describe the recognized endpoints for safety and performance or a specific safety or performance concern to be scrutinized	N/A – related keywords are not deemed required for the objective of search
Retained combination and justification
Retained combination of terms: Device Name AND Indications Device Name AND age Justification: The combination of keywords needs to be considered sufficient to collect all clinical evidence relevant to the subject/equivalent devices. For a comprehensive collection of articles for the subject device, the device name has been retained as primary keyword. For the indications for which the device is used, it has not been deemed necessary to select keywords related to the intervention or outcomes, the characteristics related to the population has been deemed sufficiently broad. Hence the retained combinations above are evaluated sufficient for a comprehensive collection of articles for the objective of S&P of the subject device.

Literature search queries for S&P

Table 16: Search queries for S&P

Literature database	Strategy	Detailed limitations	Detailed query
Embase	Device Name AND Indications	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
	Device Name AND age

Pubmed	Device Name AND Indications	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
	Device Name AND age

Cochrane Library	Device Name AND Indications	Content type: Cochrane Review Trials Cochrane Library publication date: Between Month YYYY and Month YYYY Search word variations: activated	All Text:
	Device Name AND age		All Text:
			All Text:
Google Scholar	Device Name AND Indications	Article: activated Any type: activated Custom range: YYYY – YYYY Include citations: activated
	Device Name AND age

EU Clinical Trials Register	Device Name AND Indications	Select Date Range: YYYY-MM-DD to YYYY-MM-DD Results Status: Trials with results
	Device Name AND age

Clinicaltrials.gov	Device Name AND Indications	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:
	Device Name AND age		Other terms:
			Other terms:
Previous CER: XXX rev.1	–	N/A – all articles included in the previous CER will be re-screened to confirm their suitability.

Existing search	Objective	Number of articles to be screened	Gap search?	If yes, end date of search
Document Number and revision	X		XX-MM-YYYY	XX-MM-YYYY	XX	Yes/No	XX-MM-YYYY
	X	XX-MM-YYYY	XX-MM-YYYY	XX	Yes/No	XX-MM-YYYY

Vigilance/recall search strategy

SoA search terms for vigilance/recall

The following table describes the search terms that will be used for the identification of vigilance/recall relevant to the SoA of [Device short name].

Table 17: PICO terms for SoA via vigilance/recall

PICO	Description	Terms for vigilance/recall search	Retained combination and justification
Population	N/A – No vigilance/recall database has been selected for the objective of SoA.
Intervention
Comparator
Outcomes

AC search terms for vigilance/recall

The following table describes the search terms that will be used for the identification of vigilance/recall relevant to the AC of [Device short name].

Table 18: PICO terms for AC via vigilance/recall

PICO	Description	Terms for vigilance/recall search
Population	Same as PICO terms for AC via literature	N/A – related keywords are not deemed required for the objective of search
Intervention	Same as PICO terms for AC via literature	N/A – related keywords are not deemed required for the objective of search
Comparator	Same as PICO terms for AC via literature	Similar devices: xxx xxx
Outcomes	Same as PICO terms for AC via literature	N/A – related keywords are not deemed required for the objective of search
Retained combination and justification
Retained combination of terms: Similar device (Manufacturer Name AND Device Name) Justification: e.g., All selected databases for vigilance and recall, have a field to indicate the device involved as well as the associated manufacturer name. Hence the use of similar device names and manufacturer names is deemed relevant and sufficient to retrieve all specific events related to similar devices to establish the AC.

S&P search terms for vigilance/recall

The following table describes the search terms that will be used for the identification of vigilance/recall relevant to the S&P of [Device short name].

Table 19: PICO terms for S&P via vigilance/recall

PICO	Description	Terms for vigilance/recall search
Population	Same as PICO terms for S&P via literature	N/A – related keywords are not deemed required for the objective of search
Intervention	Same as PICO terms for S&P via literature	Device Name: xxx Manufacturer Name: xxx
Comparator	N/A – the searches for S&P are focused on the subject device
Outcomes	Same as PICO terms for S&P via literature	N/A – related keywords are not deemed required for the objective of search
Retained combination and justification
Retained combination of terms: Manufacturer Name AND Device Name Justification: e.g., All selected databases for vigilance and recall, have a field to indicate the device involved as well as the associated manufacturer name. As the device name is too generic, non-relevant events can be retrieved, if it is used alone. Hence the use of device name and manufacturer name is deemed more relevant and sufficient to retrieve all specific events related to the subject device.

Vigilance / Recall search queries and results

Based on the combination of keywords selected via the PICO approach and using the appropriate search limitations, the vigilance/recall search queries have been defined for each database selected. The following table describes the search queries for the identification of vigilance/recall relevant to the AC of S&P and the S&P of [Device short name].

No vigilance/recall search will be implemented to establish the SoA of the medical condition treated/diagnosed by [device short name].

Table 20: Search queries in vigilance / recall databases

Literature database	Objective	Strategy	General limitations	Keywords
FDA MAUDE	AC	Similar device (Name And manufacturer name)	Date Report Received by FDA: MM/DD/YYYY to MM/DD/YYYY	Manufacturer: Brand Name: Product Code : Note: other fields are empty
FDA MAUDE	S&P	Manufacturer Name AND Device Name	Date Report Received by FDA: MM/DD/YYYY to MM/DD/YYYY	Manufacturer: Brand Name: Product Code : Note: other fields are empty
FDA Medical Device Recalls	AC	Similar device (Name And manufacturer name)	Recall Date : MM/DD/YYYY to MM/DD/YYYY	Product Name : Recalling Firm : Product Code : PMA/510(K) Number : Note: other fields are empty
FDA Medical Device Recalls	S&P	Manufacturer Name AND Device Name	Recall Date : MM/DD/YYYY to MM/DD/YYYY	Product Name : Recalling Firm : Product Code : PMA/510(K) Number : Note: other fields are empty
FDA TPLC	AC	Similar device (Name And manufacturer name)	Since : YYYY	Product Code : Note: other fields are empty
ANSM safety information	AC	Similar device (Name And manufacturer name)	Type : DEFAUT QUALITE, INFORMATION AUX UTILISATEURS, RAPPEL DE PRODUIT Produits de santé : Dispositifs médicaux Date : from DD/MM/YYYY to DD/MM/YYYY	: Note: other fields are empty
ANSM safety information	S&P	Manufacturer Name AND Device Name		: Note: other fields are empty
Bfarm Field Corrective Actions	AC	Similar device (Name And manufacturer name)	Category : Medical devices Product group of field corrective actions: select or empty Period: select	Search item : Note: other fields are empty
Bfarm Field Corrective Actions	S&P	Manufacturer Name AND Device Name		Search item : Note: other fields are empty
MHRA Alerts, recalls and safety information: drugs and medical devices	AC	Similar device (Name And manufacturer name)	Message type : Field safety notice, Device safety information Medical specialty: select or empty Issued after: DD/MM/YYYY; Issued before: DD/MM/YYYY	Search : Note: other fields are empty
	S&P	Manufacturer Name AND Device Name		Search : Note: other fields are empty
SwissMedic – FSCA and recall	AC	Similar device (Name And manufacturer name)	From; DD/MM/YYYY To: DD/MM/YYYY	Please enter a search term: Note: other fields are empty
SwissMedic – FSCA and recall	S&P	Manufacturer Name AND Device Name	From; DD/MM/YYYY To: DD/MM/YYYY	Please enter a search term: Note: other fields are empty
DAEN (Database of Adverse Event Notifications) – medical devices	AC	Similar device (Name And manufacturer name)	Select date range : From : YYYY Month DD To : YYYY Month DD	Select medical devices : Note: other fields are empty
	S&P	Manufacturer Name AND Device Name		Select medical devices : Note: other fields are empty
SARA (System for Australian Recall Actions)	AC	Similar device (Name And manufacturer name)	Select product type : Medical Device Select date range : From : YYYY Month DD To : YYYY Month DD	Select products : Note: other fields are empty
SARA (System for Australian Recall Actions)	S&P	Manufacturer Name AND Device Name		Select products : Note: other fields are empty
Canadian recalls and safety alerts (advanced search)	AC	Similar device (Name And manufacturer name)	Type: Recall Issue: Medical devices Last updated: YYYY	Search: Note: other fields are empty
Canadian recalls and safety alerts (advanced search)	S&P	Manufacturer Name AND Device Name	Type: Recall Issue: Medical devices Last updated: YYYY	Search: Note: other fields are empty

Search reports

The implementation of this search protocol will be documented via the following reports:

Literature search report for S&P
Literature search report for SoA
Literature search report for AC
Search report for vigilance / recall
Report on existing literature & literature gap search

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SKU LEX-FORM-EU-004 rev.1 Category Clinical Documents

Clinical data search protocol