Systematic Reviews for the Entire Medical Device Lifecycle
Under the EU MDR and IVDR, systematic literature reviews are mandatory throughout the device lifecycle, from initial clinical evaluation to post-market surveillance. Puraite delivers audit-ready, traceable literature reviews for CERs, performance evaluations, PMCF and risk management.
Request a MedTech WalkthroughThe Challenge
The MDR transition has made clinical evidence requirements significantly more demanding.
Clinical Evaluation Reports (CERs)
Under MDR Article 61 and Annex XIV, manufacturers must conduct systematic literature reviews to establish the current state of the art and evaluate clinical evidence for their device. MDCG 2020-5 defines the equivalence criteria; MDCG 2020-13 guides the clinical evaluation assessment.
Post-Market Clinical Follow-up (PMCF)
MDR Article 61(11) and Annex XIV Part B require manufacturers to proactively and continuously collect and evaluate clinical data throughout the device's lifetime. Systematic literature review is a core PMCF activity for identifying emerging safety signals and evidence gaps.
Risk Management (ISO 14971)
Systematic literature review supports hazard identification per ISO 14971:2019 by identifying known complications, adverse events and failure modes associated with the device type and intended use. Reproducible, structured evidence retrieval is essential for demonstrating due diligence.
State-of-the-Art Documentation
Establishing the current state of the art for each device indication is a foundational requirement of clinical evaluation under MDR. Keeping this documentation current across multiple product lines, indications and device generations is a persistent resource challenge.
How Puraite Helps
Specific workflows where Puraite accelerates regulated evidence work.
CER Systematic Literature Review
Systematic identification of clinical data for the subject device, equivalent devices and current state of the art. PICO-aligned search strategy, dual screening with AI-assisted rationale, risk-of-bias assessment using validated tools (RoB 2, Newcastle-Ottawa Scale), and MDCG-aligned evidence tables.
PMCF Evidence Gap Analysis
Structured mapping of existing published evidence against the device's clinical claims and intended purpose. Systematic identification of evidence gaps that may require PMCF studies, registry participation or additional literature monitoring.
IVDR Performance Evaluation
Systematic literature review for in-vitro diagnostic performance evaluation reports. Structured identification and data extraction from diagnostic accuracy studies, including sensitivity, specificity, positive/negative predictive values per IVDR Annex XIII.
Equivalence Argumentation Support
Systematic literature retrieval and screening for equivalent and competitor devices. Structured comparison tables covering clinical, technical and biological equivalence characteristics per MDR Annex XIV and MDCG 2020-5 criteria.
Preparing a CER or PMCF plan?
See how Puraite handles an MDR-compliant literature review. Request a 30-minute walkthrough.