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Resources for Researching Medical Devices Using 
Publicly Available Databases
Speaker
Sara VanWyk, MPH, CCRP, RAC, MWC / Clinical Evaluation 
Reporting, LLC, St. Petersburg, FL

By Thi Nguyen, BS
The clinical evaluation of medical devices marketed in the 
European Union (EU) is influenced by guidance from the 
Medical Device Coordination Group (MDCG) and still-rel-
evant sections of MEDDEV 2.7/1 Rev 4 (Medical Devices 
Document 2.7/1 Revision 4; June 2016). In her presentation 
at the 2022 AMWA Southeast Regional Conference, Sara 
VanWyk provided an overview of relevant guidance on the 
clinical evaluation report, publicly available databases for 
literature searches, and content and release information for 
summaries of safety and clinical performance (SSCPs).

Background
Historically, requirements for medical device regulation in 
Europe were established by the Medical Devices Directive 
(MDD) and the Active Implantable Medical Device 
Directive (AIMDD). As of late, the requirements have been 
transitioning to follow the Medical Devices Regulation 
(MDR) and In Vitro Diagnostic Regulation (IVDR).
 To show evidence of having met the EU MDR gen-
eral safety and performance requirements, manufactur-
ers plan and report on the clinical evaluation of medical 
devices marketed in the EU; such evaluations align with 
the MEDDEV and MDCG guidance documents, including 
MEDDEV 2.7/1 Rev 4, MDCG 2020-6, and MDCG 2020-13 
(among others). The first relevant guidance is MEDDEV 
2.7/1 Rev. 4 (June 2016), which offers manufacturers and 
notified bodies guidance on clinical evaluation under direc-
tives 93/42/EEC and 90/385/EEC. The second guidance is 
MDCG 2020-6, which explains sufficient clinical evidence 
for legacy devices.
 The third guidance is MDCG 2020-13, which offers 
a template for the clinical evaluation assessment report 
(CEAR). Each section of guidance contains pearls of wisdom 
regarding the device characteristics and evidence described 
in a clinical evaluation report, including the device descrip-
tion, published literature, clinical investigations, and clinical 
experience. This information may additionally be described 
in an SSCP, depending on the type of device.

Device Description
Methods for describing the device under evaluation are 
outlined in MDCG 2020-13 Section C. To locate a device 
description, one can use the manufacturer’s website, the 

United States (US) Food and Drug Administration (FDA) 
510(k) Premarket Notification Database (https://www.
accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm),  
the FDA Premarket Approval (PMA) database, or the 
Therapeutic Goods Administration (TGA) Australian Registry 
of Therapeutic Goods (ARTG) database.

Published Literature
What literature qualifies for evaluation depends on the 
associated data, which can be categorized as either pivotal 
data or other data according to Section 9.3.2 of MEDDEV 
2.7/1 Rev 4. Pivotal data must directly demonstrate ade-
quate safety and performance (of sufficient quality and gen-
erated with the device under evaluation or the equivalent), 
whereas other data only play a supportive role. The same 
guidance also offers examples of data that lack scientific 
validity in Appendix A6. In terms of where to find published 
literature, many options exist, and Ms Vanwyk highly rec-
ommends PubMed, Embase, and the Cochrane Database 
for Systematic Reviews. However, other databases such as 
Europe PMC and Google Scholar can also be viable options.

Clinical Investigations
In addition to searching published literature, writers are 
also encouraged to search data from clinical investigations. 
This search can help writers identify data that are not found 
by other means. To find clinical investigation data, writers 
can use clinicaltrials.gov, the World Health Organization 
International Clinical Trials Registry Platform (WHO 
ICTRP), and Cochrane Central, although the EU Clinical 
Trials Register can also be a good resource.

Clinical Experience
Clinical experience includes data on suspected device-as-
sociated deaths, serious injuries, and malfunctions that can 
feed into medical device reports (used in the US) and med-
ical device vigilance (used in the EU). In the US, the FDA 
can use clinical experience to monitor device performance, 
detect potential device-related safety issues, and contrib-
ute to benefit-risk assessments. Data can be compiled from 
mandatory reporters (eg, manufacturers, importers, and 
user facilities) and voluntary reporters (eg, health care pro-
fessionals, patients, and consumers).
 It is important to note that clinical experience can have 
limited utility because of passive surveillance. Many clini-
cal experience databases exist throughout the world, with 
the US having the most databases. Available databases per 
country are as follows:

• US – FDA Manufacturer and User Device Experience 
(MAUDE), FDA Recalls, and FDA Total Product Life 

Cycle (TPLC) databases

http://www.amwajournal.org
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm


AMWAJournal.org     60Think Like an Editor: Improving Document Quality for Regulatory Submissions

• Canada – Health Canada Medical Device Incidents and 
Health Canada Recalls and Safety Alerts databases

• United Kingdom – Medicines and Healthcare prod-
ucts Regulatory Agency (MHRA) database

• Germany – Federal Institute for Drugs and Medical 
Devices (BfArM) Field Corrective Actions and BfArM 
Recommendations databases

• Switzerland – SwissMedic Field Safety and Corrective 
Actions (FSCA) and SwissMedic Recalls databases

• Australia – TGA Device Adverse Even Notification 
(DAEN) and TGA System for Australian Recall Actions 

(SARA) databases

Other Resources
Other helpful resources include SSCPs, which provide 
publicly accessible, up-to-date summaries of clinical 
data and other information about the safety and clinical 
performance of a medical device. SSCP information can be 
accessed through https://ec.europa.eu/tools/eudamed/#/
screen/home.

Thi Nguyen is a medical writer at ICON plc based in Fort 
Lauderdale, FL.

Author contact: h.nguyen15@umiami.edu

Think Like an Editor: Improving Document Quality for 
Regulatory Submissions
Speaker
Callie Compton, MA / Senior Technical Editor, Certara 
Synchrogenix, Nashville, TN

By Paris Karr, PharmD
Quality control (QC) is an integral part of ensuring accu-
rate and consistent regulatory writing submissions. QC can 
be essentially defined as a process of checking consistency 
against a standard. However, in a writing context, QC is 
more specific than just “review.”
 Considering different types of reviews (data, subject 
matter expert [SME], and editorial), the omission of each 
kind can have different implications. Data and SME reviews 
can be critical for regulatory submissions, whereas an edito-
rial review is often necessary for document appearance.
 In her presentation at AMWA’s 2022 Southeast Regional 
Conference, Callie Compton, Senior Technical Editor at 
Certara Synchrogenix, identified common issues in the QC 
process and discussed strategies for regulatory medical 
writers to ensure a successful QC process.

Common Issues
Compton began by outlining several examples of document 

inconsistency. Such instances can include (but are not  
limited to) a document not aligning with sources, incon-
sistent terminology and style conventions, and errors in 
grammar, punctuation, and/or spelling. Furthermore, she 
also identified issues that may arise downstream in the QC 
process, such as inadequate time allotted for QC, vague, 
unclear expectations and/or instructions, and misplaced 
expectations for role/review type.

Document Consistency
Compton suggested that identifying specific standards that 
govern the document is a crucial step for QC. However, 
before the actual process of QC, regulatory medical writers 
should consider asking the following questions to ensure 
document consistency:

• Does my writing align with its source(s)?
• Is my writing easy to navigate?
• Do I write about the same content in the same way?
• Do the same components in my writing look  

the same?

 Regulatory writing may often require checking exter-
nal sources such as a tables, listings, and figures docu-
ment or a clinical study report. To ensure that the writing is 
aligned with external content, it is important to clearly iden-
tify sources in the document and to keep them organized. 
Compton illustrated that source references should specify 
document identifiers, such as the study identification,  
version number, or date, if applicable.
 Consistent terminology and style conventions are also 
critical for regulatory documents. Compton pointed out  
that a style guide can be an important tool to help maintain  
uniformity when there can be many acceptable writing  
conventions. A style guide may specify, for instance,

• use of company/drug name
• preferred template/toolbar
• abbreviations/terminology, and/or

• usage (eg, patient vs subject).

 Compton elaborated that “style” may refer to 2 different 
things: writing composition or formatting. In discussing the 
latter, a QC checklist can help guide the medical writer to 
consistently perform specific assessments, line edits, and 
spelling checks as a process.

QC Process
Given its deadline-oriented and collaborative aspects, 
regulatory writing requires effective time management. 
Compton pointed out that inadequate time allotments for 
QC during development stages or at the end of a project can 
lead to considerable quality risk. For that reason, the start of 

http://www.amwajournal.org
https://ec.europa.eu/tools/eudamed/#/screen/home
https://ec.europa.eu/tools/eudamed/#/screen/home



