,Clinical Evaluation of Medical Devices Overview
Freyr provides end-to-end Clinical Evaluation services with rigorous methodology, transparent State-Of-The-Art (SOTA) justification, and lifecycle maintenance. From CEP scoping to CER writing and PMCF, we align evidence to General Safety and Performance Requirements (GSPRs) for smooth EU MDR compliance and surveillance.
Freyr’s End-to-End Clinical Evaluation Services
Freyr designs device-specific Clinical Evaluation Plans (CEP) that define indications, intended purpose, claims, acceptance criteria, and equivalence strategy, with a reproducible SLR protocol. We set traceability and appraisal criteria mapped to GSPRs, establishing the foundation for a compliant clinical evaluation report MDR pathway under EU MDR 2017/745.
Freyr conducts rigorous Systematic Literature Reviews (SLR) featuring multi-database search strategies, dual level screening, critical appraisal, and transparent evidence synthesis. We establish State-Of-The-Art (SOTA) and generate strong clinical evidence aligned with the device’s indications and claims, directly supporting CER requirements under EU MDR 2017/745. Our deliverables include PRISMA-style documentation and traceability matrices ready for Notified Body review.
Freyr authors NB-ready Clinical Evaluation Reports (CER) that clearly present device description, SOTA, clinical evidence, benefit–risk analysis, residual risks, and PMCF plans all mapped to GSPRs. We also manage ongoing CER updates in alignment with PMS and PSUR cycles, integrating vigilance findings and new literature to ensure your MDR CER remains current and inspection-ready.
Freyr prepares concise, compliant SSCP documents as per EU MDR format, transparently communicating safety, clinical performance, intended purpose, indications, and residual risks. We ensure SSCP content is traceable to your CER, PMS, and PMCF evidence, supporting Notified Body expectations and reinforcing stakeholder trust across EU market surveillance.
Freyr’s Tailored Clinical Evaluation Services
Clinical Evaluation Gap Analysis
Freyr pinpoints gaps against MDR CER expectations and GSPRs, auditing methodology, equivalence, and benefit–risk justification. We deliver a prioritized remediation plan, targeted evidence recommendations, and clear Notified Body– ready rationales, ensuring the clinical evaluation process advances smoothly and avoids unnecessary NCs.
Tailored Literature Strategy & SLR
Freyr develops device-specific SLR strategies, runs multi-database searches, and performs dual screening with rigorous critical appraisal. We synthesize clinical evidence to establish SOTA and strengthen Clinical Evaluation Reports (CER) for medical devices in alignment with EU MDR requirements.
SME Support for Non-conformity Review
When Notified Bodies raise NCs, Freyr mobilizes senior medical writers and regulatory SMEs to analyze findings, sharpen equivalence and benefit–risk justifications, refine SLR methods, and craft persuasive responses—reducing review cycles and accelerating MDR CER approvals.
SOP Writing
Freyr develops MDR-aligned SOPs that operationalize the clinical evaluation process end-to-end—CEP, literature search, appraisal, equivalence, benefit–risk, and traceability. Our SOPs define clear roles, tools, and QC checkpoints to standardize CER outputs and withstand Notified Body audits.
Annual Maintenance of Clinical Reports
Freyr manages annual CER maintenance by scheduling timely updates that integrate PMS trends, vigilance data, and PMCF findings into PSURs. We ensure your clinical evaluation report is MDR current, traceable, and inspectionready across the EU MDR 2017/745 lifecycle.
Full-Time Employee (FTE) Support
Freyr embeds dedicated FTE specialists into your team to accelerate CER writing, rigorous SLR, equivalence assessments, and PMCF design. We add scalable capacity and NB-facing expertise, improving MDR CER quality, traceability, and submission efficiency.
Procedural Trainings
Freyr delivers tailored procedural training on clinical evaluation under MDR, SLR methodology, benefit–risk and equivalence justification, and SSCP/PSUR integration. We upskill your teams with practical workshops and templates, ensuring audit-ready, consistent clinical evaluation and CER outputs.
Freyr’s Clinical Evaluation Services
Regulatory Compliance
Freyr simplifies navigation of the complex landscape of the European Medical Device Regulations (EU MDR), ensuring your clinical evaluations align with the EU MDR requirements and helping you achieve and maintain compliance in the European Union (EU) market.
Specializing in catering to various international regulatory frameworks, including those of the United Kingdom (UK), CDSCO (Central Drugs Standard Control Organization), SFDA (Saudi Food and Drug Authority), and more, Freyr's services are designed to meet the unique demands of each region.
Frequently Asked Questions (FAQs)
1) What is a Clinical Evaluation Report (CER) under EU MDR, and why does it matter?
A CER documents the clinical evaluation demonstrating conformity with the MDR’s General Safety and Performance Requirements. It synthesizes clinical data, appraisal methods, and benefit–risk conclusions and defines ongoing evidence needs. It is mandatory for CE marking and must be maintained throughout the device lifecycle under Article 61 and Annex XIV.
2) What is a Clinical Evaluation Plan (CEP) and what must it include?
The CEP is the blueprint for clinical evaluation. Annex XIV Part A requires, at a minimum: GSPRs requiring clinical support, intended purpose and target patient groups, clinical benefits and outcome parameters, methods for safety/performance assessment, benefit–risk criteria, equivalence approach, and a clinical development plan linking to PMCF provisions. It must be created and updated throughout the lifecycle.
3) What should a CER include according to Annex XIV Part A / MEDDEV 2.7/1 rev.4?
A CER must describe the device and intended purpose; detail clinical evaluation methods (e.g., literature search and appraisal); compile and analyze clinical data; justify equivalence; assess benefit–risk and residual risks; and demonstrates conformity with applicable GSPRs. MEDDEV 2.7/1 rev.4 remains the key methodological guide for conducting SLRs, appraisal, and reporting structure.
4) How often should a CER be updated under MDR?
Update frequency is risk-based and justified by the manufacturer. High-risk devices are generally updated more frequently
(often annually), while lower-risk devices may have longer intervals; updates must reflect new clinical evidence and PMS/PSUR insights and precede submissions to Notified Bodies. MEDDEV and MDR practice support a lifecycle, livingdocument approach.
5) Can a CER rely only on literature, or is a new clinical investigation required?
Under the MDR, a literature-based CER is acceptable when existing clinical data (including justified equivalence and postmarket evidence) are sufficient to demonstrate safety, performance, and a positive benefit–risk profile for the device’s intended purpose. If evidence gaps remain, new clinical investigations are required in accordance with Articles 61 and 62–81 and Annex XV. MEDDEV 2.7/1 rev.4 provides the methodological standards for literature.
6) How is equivalence demonstrated under MDR for clinical evaluation?
Equivalence must be justified across clinical, technical, and biological characteristics, with sufficient access to data on the comparable device. MDCG 2020-5 details expectations and highlights differences from MEDDEV 2.7/1 rev.4. Robust rationale, gap analysis, and traceability are essential to support reliance on external data in the CER.
7) What is the SSCP, and how does it relate to the CER?
The Summary of Safety and Clinical Performance (SSCP) is a public document required for implantable and Class III devices. It must reflect the CER’s conclusions, align with PMS/PMCF evidence, and follow Article 32 and MDCG 2019-9’s template to support transparency and clinical decision-making.
8) Why is Freyr considered a leading partner for Clinical Evaluation services?
Freyr applies an MDR-focused methodology across the entire clinical evaluation pathway, from CEP development to CER completion. We conduct reproducible SLRs, justify equivalence and benefit–risk with transparent traceability to GSPRs, and implement MDR requirements through audit-ready SOPs, SSCP alignment, and structured update cycles. Our approach includes indication-specific literature methods and detailed gap analyses. Using Notified-Body–tested templates and reviewer-style critiques, we streamline review cycles, strengthen evidence quality, and ensure CERs remain fully inspectionready
