Clinical evaluation is a systematic and ongoing process used to collect, appraise, and analyse clinical data to demonstrate the safety and performance of a medical device throughout its lifecycle (GHTF Study Group 5, 2007).
Literature review plays a central role in clinical evaluation because published scientific evidence can support claims related to clinical performance, safety, and benefit–risk acceptability (MEDDEV 2.7/1 rev.4, 2016).
A well-designed literature search must follow a structured and reproducible methodology to ensure transparency, traceability, and scientific validity (Pati et al., 2017).
- Define the Clinical Question
The first step in a literature search is to define a clear and answerable clinical question aligned with the device’s intended purpose and clinical claims (Ecker & Skelly, 2010).
Structured frameworks such as PICO (Patient, Intervention, Comparator, Outcome) help transform broad research questions into searchable clinical questions (Ecker & Skelly, 2010).
A focused clinical question improves search efficiency and reduces irrelevant results during evidence identification (Ecker & Skelly, 2010).
- Develop a Literature Search Strategy
A literature search strategy should define keywords, synonyms, inclusion/exclusion criteria, and selected databases before the search begins (MEDDEV 2.7/1 rev.4, 2016).
Using multiple databases such as PubMed, MEDLINE, EMBASE, and the Cochrane Library increases the likelihood of identifying all relevant clinical evidence (Ecker & Skelly, 2010).
Systematic searching ensures reproducibility and minimizes selection bias during evidence collection (Pati et al., 2017).
Documentation of the search methodology is essential so that the process can be reviewed, repeated, and audited if necessary (MEDDEV 2.7/1 rev.4, 2016).
- Identify Relevant Clinical Data
Clinical data used in a clinical evaluation may originate from clinical investigations, scientific literature, post-market clinical experience, or equivalent devices (GHTF Study Group 5, 2007).
Published literature represents an important source of clinical evidence, particularly for established technologies or when equivalence can be demonstrated (MEDDEV 2.7/1 rev.4, 2016).
Systematic reviews provide stronger evidence than single studies because they integrate findings from multiple research sources (Pati et al., 2017).
- Appraise the Scientific Quality of Evidence
Not all literature has equal scientific value, and each study must be critically appraised for methodological quality, relevance, and risk of bias (MEDDEV 2.7/1 rev.4, 2016).
The appraisal process evaluates whether the identified clinical data are sufficient to demonstrate safety, performance, and clinical benefit (GHTF Study Group 5, 2007).
Transparent evaluation criteria improve the credibility and reliability of the clinical evaluation process (Pati et al., 2017).
- Analyse and Synthesize the Evidence
After appraisal, the clinical data are analysed collectively to determine whether the device meets safety and performance requirements (GHTF Study Group 5, 2007).
This step includes assessing benefit–risk balance, clinical performance, and potential undesirable effects associated with the device (MEDDEV 2.7/1 rev.4, 2016).
The conclusions of this process are documented in the Clinical Evaluation Report (CER), which forms part of the technical documentation (GHTF Study Group 5, 2007).
- Maintain the Literature Review as a Living Process
Clinical evaluation is not a one-time activity but a lifecycle process requiring periodic updates as new clinical data become available (GHTF Study Group 5, 2007).
Post-market clinical data, registries, and real-world evidence may complement literature findings and strengthen clinical evidence over time (Valla et al., 2023).
Continuous literature surveillance ensures that the benefit–risk profile remains acceptable throughout the device lifecycle (MEDDEV 2.7/1 rev.4, 2016).
References
Ecker, E. D., & Skelly, A. C. (2010). Conducting a winning literature search. Evidence-Based Spine-Care Journal, 1(1), 9–14.
GHTF Study Group 5. (2007). Clinical Evaluation (SG5/N2R8). Global Harmonization Task Force.
European Commission. (2016). MEDDEV 2.7/1 Revision 4 — Clinical Evaluation: A Guide for Manufacturers and Notified Bodies.
Pati, D., & Lorusso, L. N. (2017). How to write a systematic review of the literature. Health Environments Research & Design Journal.
Valla, V., Tzelepi, K., Charitou, P., Lewis, A., Polatidis, B., Koukoura, A., et al. (2023). Use of real-world evidence for international regulatory decision making in medical devices. International Journal of Digital Health, 3(1).
