Clinical Evaluation of Medical Devices

 Freyr serves as a reliable partner for the clinical evaluation of medical devices across all device classes. We develop comprehensive Clinical Evaluation Plans (CEP), perform reproducible Systematic Literature Reviews (SLR), and prepare Clinical Evaluation Reports (CER) that clearly demonstrate safety, performance, and EU MDR compliance — ready for Notified Body assessment.

Clinical Evaluation of Medical Devices Overview

Freyr delivers end-to-end Clinical Evaluation services supported by rigorous methodology, transparent State-Of-The-Art (SOTA) justification, and lifecycle maintenance. From CEP definition to CER authoring and PMCF integration, we align clinical evidence to General Safety and Performance Requirements (GSPRs) to support seamless EU MDR compliance and surveillance.

Clinical Evaluation Plan (CEP)

Freyr develops device-specific CEPs defining intended purpose, indications, claims, acceptance criteria, and equivalence strategy, supported by a reproducible SLR protocol. We establish traceability and appraisal frameworks mapped to GSPRs, forming a compliant foundation for the MDR clinical evaluation pathway under EU MDR 2017/745.

Systematic Literature Review (SLR)

Freyr performs structured SLRs using multi-database search strategies, dual-stage screening, critical appraisal, and transparent evidence synthesis. We establish SOTA and generate robust clinical evidence aligned with device indications and claims, directly supporting CER requirements under EU MDR 2017/745. Deliverables include PRISMA-style documentation and traceability matrices prepared for Notified Body review.

Clinical Evaluation Report (CER)

Freyr produces Notified Body-ready CERs that clearly present device description, SOTA, clinical evidence, benefit–risk analysis, residual risks, and PMCF strategy — all mapped to GSPRs. We manage lifecycle CER updates aligned with PMS and PSUR cycles, incorporating vigilance data and new literature to maintain inspection-ready MDR compliance.

Summary of Safety and Clinical Performance (SSCP)

Freyr prepares compliant SSCP documents in the EU MDR format, transparently communicating safety, clinical performance, intended purpose, indications, and residual risks. SSCP content is fully traceable to CER, PMS, and PMCF evidence, supporting Notified Body expectations and strengthening stakeholder confidence across EU market surveillance.

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