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Introduction: From Compliance to Confidence in Clinical Evaluation
Under the EU Medical Device Regulation (MDR 2017/745), the landscape of clinical evidence generation has undergone a major transformation. What was once a routine exercise—conducting a literature review to support device documentation—has evolved into a Regulatory cornerstone. Today, the Systematic Literature Review (SLR) stands as the backbone of every Clinical Evaluation Report (CER), driving scientific credibility, compliance, and market readiness.
A systematic literature review is more than a compliance requirement; it is a structured, transparent, and reproducible process that ensures every CER is grounded in evidence-based clinical evaluation. By applying predefined search strategies, critical appraisal techniques, and structured data synthesis, Regulatory medical writing professionals can deliver clinical narratives that are not only MDR-compliant but also defensible and globally credible.
In an increasingly evidence-driven MedTech ecosystem, a well-conducted SLR transforms the CER from a Regulatory formality into a strategic asset for clinical and commercial success.
Why Systematic Literature Reviews Matter in MDR Clinical Evaluation
A systematic literature review represents the highest standard in evidence-gathering methodology. When designed with scientific rigour, an SLR supports manufacturers in establishing:
- Clinical performance and safety evidence that substantiates device claims.
- The State of the Art (SOTA)—a benchmark for comparison against current clinical practice.
- Equivalence to predicate or similar devices, where applicable.
- Continuous clinical evidence supporting post-market surveillance and post-market clinical follow-up (PMCF).
By following a structured, auditable SLR methodology, manufacturers can substantiate clinical benefits, mitigate Regulatory risk and demonstrate ongoing MDR compliance throughout the product lifecycle.
In essence, the SLR serves as the scientific compass that guides every clinical evaluation, ensuring data integrity, reproducibility, and traceability.
A Step-by-Step Framework for Conducting Systematic Literature Reviews
Conducting a systematic literature review for medical devices requires meticulous planning and methodical execution. Following the standards outlined in MEDDEV 2.7/1 Rev. 4 and MDR Annex XIV, the process ensures consistency, transparency, and Regulatory robustness.
1. Defining the Objective and Scope
Every SLR begins with a clearly defined research question that aligns with the device’s intended purpose, indications, and clinical claims. The PICO framework (Population, Intervention, Comparator, Outcome) is commonly used to structure the objective, ensuring focus and relevance.
A well-defined objective is the foundation of a reproducible, evidence-based review—one that withstands Regulatory scrutiny.
2. Designing a Robust Literature Search Strategy
An effective search strategy combines scientific precision and Regulatory awareness. Comprehensive searches should cover databases such as PubMed, Embase, Cochrane, and Scopus, using predefined keywords, Boolean operators, and MeSH terms.
Every decision—such as database selection, time filters, and inclusion/exclusion criteria—must be fully documented to ensure transparency and reproducibility. This ensures that your SLR meets the audit-ready expectations of Notified Bodies and Regulatory reviewers.
3. Screening and Study Selection
Screening is where scientific judgment meets regulatory rigour. Retrieved citations undergo a two-level screening—first by title and abstract, followed by a full-text review.
To minimise bias, screening is typically performed by two independent reviewers, guided by predefined inclusion and exclusion criteria.
The outcome: a consistent, objective, and verifiable set of studies that form the evidence base for the clinical evaluation report.
4. Data Extraction and Quality Appraisal
Once eligible studies are identified, data are extracted using standardised templates that capture details such as study design, patient population, intervention, outcomes, and comparators.
Each study is then critically appraised for quality and bias using validated frameworks like:
Framework | Primary Use | Focus | Applies To |
|---|---|---|---|
MEDDEV 2.7/1 Rev. 4 | EU Regulatory compliance | Methodological quality, bias, relevance | All device evidence |
OCEBM (Oxford Centre for Evidence-Based Medicine) | Hierarchy of evidence | Study design level (1–5) | All interventions |
GRADE | Evidence certainty | Overall strength of evidence | Guidelines & CER summaries |
CONSORT | Reporting quality | Transparency of RCT reporting | Randomised trials only |
This structured, multi-layered approach ensures that your clinical evidence synthesis is robust, reliable, and aligned with regulatory expectations.
Clinical Evidence Integration and Interpretation
An SLR is not just about collecting data—it’s about translating evidence into insight. Extracted studies are synthesized to establish the clinical safety and performance of the device while defining the State of the Art (SOTA).
Where relevant, comparative analyses demonstrate equivalence, highlight clinical benefits, and inform benefit-risk evaluations. This integration turns data into a cohesive, evidence-based clinical narrative that strengthens the CER’s scientific and regulatory credibility.
Building a Continuous, Reproducible Evidence Framework
Clinical evaluation under the MDR is not a one-time task—it’s a continuous process. The SLR offers a lifecycle-driven framework for collecting, evaluating, and updating clinical evidence throughout the device lifecycle.
When embedded within the Quality Management System (QMS), a systematic review process ensures:
- Regular updates of clinical evidence.
- Consistency across pre-market and post-market documentation.
- Alignment with PMCF and risk management activities.
This approach ensures that manufacturers maintain an audit-ready, reproducible evidence base that evolves alongside device innovation and regulatory requirements.
Overcoming MedTech Evidence Challenges
The medical device sector presents unique challenges for systematic reviews. Randomized controlled trials (RCTs) may be limited, and data sources often include observational studies, case series, and registry analyses.
To address these realities, SLR teams must adopt flexible and inclusive methodologies that maintain scientific integrity while accommodating real-world evidence.
Robust analytical approaches—such as sensitivity analyses, bias assessment (Cochrane RoB, ROBINS-I), and meta-regression—help manage heterogeneity and ensure balanced interpretation.
Moreover, incorporating conference abstracts, post-market data, and real-world studies, when properly appraised, can provide valuable insights into ongoing device performance.
A successful SLR thus combines methodological rigor with clinical pragmatism, reflecting the dynamic nature of MedTech innovation.
Ensuring Regulatory Compliance Through Rigorous SLR Practices
Notified Bodies frequently identify insufficient methodological transparency and reproducibility gaps as leading deficiencies in Clinical Evaluation Reports. Manufacturers can mitigate these risks through fully auditable SLR protocols that include:
- Clearly defined research objectives (aligned with MDR Annex XIV).
- Documented search strategies and inclusion/exclusion criteria.
- Validated data extraction templates and quality appraisal tools.
- Comprehensive traceability from literature identification to CER synthesis.
By embedding these best practices, organisations ensure audit readiness, Regulatory compliance, and scientific defensibility. A well-structured SLR is not just a compliance exercise—it’s a reflection of a company’s commitment to transparency, quality, and clinical excellence.
Freyr’s Expert Approach to Systematic Literature Reviews
At Freyr, we understand that a systematic literature review is not merely a Regulatory necessity—it’s an opportunity to showcase clinical credibility.
Our medical writing experts deliver end-to-end SLR solutions that align with MDR and MEDDEV 2.7/1 Rev. 4 standards, ensuring every CER we support is comprehensive, traceable and audit-ready.
Our SLR Services Include:
- End-to-end search design and documentation across major scientific databases.
- Dual-reviewer screening and bias assessment for objectivity and reproducibility.
- Data extraction and synthesis using validated frameworks and standardised templates.
- Evidence integration with CERs, PMCFs, and risk management reports to ensure lifecycle continuity.
Freyr’s methodologies are designed to transform SLRs from Regulatory obligations into strategic tools that enhance clinical credibility and accelerate market approvals.
Why Choose Freyr for SLR Excellence
A well-executed systematic literature review forms the backbone of a credible Clinical Evaluation Report. At Freyr, we merge scientific depth, Regulatory precision, and methodological excellence to create SLRs that withstand rigorous review.
By embracing reproducible, and audit-ready workflows, manufacturers can transform SLRs into strategic assets that:
- Strengthen Regulatory compliance and benefit-risk evaluation.
- Support faster market entry and global Regulatory submissions.
- Demonstrate a commitment to clinical excellence and innovation.
Transform your clinical evidence into a strategic advantage. Choose Freyr for MDR-ready, audit-proof, and scientifically robust systematic literature reviews that empower global device success.
