Clinical Evaluation For Medical Devices
Clinical Evaluation Reports For Medical Devices, Done Right
EU MDR 2017/745 compliant Clinical Evaluation Reports developed by experienced regulatory and clinical writers. We deliver comprehensive clinical data evaluation, systematic literature reviews, and structured benefit–risk analyses designed to support notified body review.
What We Do: Comprehensive Clinical Evaluation
Report (CER) Support
MEDRA offers specialized support across the entire CER lifecycle, from clinical evidence strategy and literature evaluation to benefit-risk analysis and notified body submission support. Our services are aligned with EU MDR requirements and applicable guidance to support robust, defensible clinical evaluations.
CER Strategy & Planning
- EU MDR-aligned compliance and readiness assessments.
- Equivalence determination and justification.State-of-the-art analysis.
- Clinical evidence strategy and gap analysis.
- Evidence planning and clinical development plan support
CER Authoring & Documentation
- Full CER development in accordance with MEDDEV 2.7/1 Rev.4
- Device description and intended purpose development
- Benefit-risk analysis and conclusions
- Preclinical and clinical data summaries
- Summary of Safety and Clinical Performance (SSCP) development
Systematic Literature Review Support
- CER-focused literature search strategy development
- Systematic database searches and documentation
- Application of predefined inclusion and exclusion criteria
- Critical appraisal of clinical relevance and quality
- Traceable reporting of methods and results
Clinical Data & Evidence Synthesis
- Integration of clinical, PMCF, and post-market data
- Structured appraisal of safety and performance evidence
- State of the art analysis within current clinical practice
- Benefit-risk analysis aligned with Annex XIV expectations
- Clear evidence synthesis with traceable tables
Quality & Compliance Review
- Internal quality, consistency, and traceability reviews
- Verification of alignment with EU MDR Article 61 requirements
- Review against applicable MEDDEV guidance and Annex XIV alignment
- Final CER readiness and submission review
- Cross-check of evidence tables, references, and source documentation
Regulatory & Lifecycle Support
- Regulatory review support aligned with notified body expectations
- Preparation of written responses to notified body questions
- CER updates and periodic review support
- PMCF plan and PMCF Evaluation Report development
- Ongoing clinical evidence documentation across the device lifecycle
How We Work
Our Proven 5-Step CER Workflow
We deliver efficient, EU MDR-compliant Clinical Evaluation Reports through a transparent, collaborative
process designed to satisfy notified body expectations.
1
Strategic Scoping & Regulatory Alignment
We align early on device classification, intended purpose, equivalence approach, and clinical evidence requirements to establish a clear, defensible path to EU MDR alignment.
2
Clinical Evidence & Literature Review
We conduct comprehensive systematic literature reviews and assess all available clinical data including pre-clinical studies, clinical investigations, PMCF data, and vigilance information to build a robust evidence base.
3
Data Appraisal & Benefit-Risk Analysis
We critically appraise all clinical data sources, establish state of the art benchmarks, and develop structured benefit-risk analyses aligned with MEDDEV 2.7/1 Rev.4 expectations.
4
CER Development & Quality Review
We develop a comprehensive CER per Annex XIV requirements, applying rigorous quality, consistency, and traceability reviews to ensure clarity and regulatory defensibility.
5
Regulatory Review & Lifecycle Support
We support regulatory review readiness through final CER package preparation, written response development for regulatory questions, and ongoing CER updates across the device lifecycle.
Clinical Evaluation Report Support
MEDRA provides strategic, EU MDR-aligned CER support for medical device manufacturers. Our approach combines regulatory expertise, scientific rigor, and clear documentation to support robust clinical evaluations and informed regulatory review.
Dedicated Clinical Evaluation Experts
Clients are supported by experienced CER writers who lead equivalence assessments, literature review strategy, and benefit-risk analysis, ensuring a focused, defensible approach tailored to each device and its clinical context.
Integrated Authoring Across CER Sections
We develop and integrate clinical evidence, literature analysis, and benefit-risk conclusions per MEDDEV 2.7/1 Rev.4 and Annex XIV requirements, ensuring consistency across device description, state of the art analysis, and clinical data appraisal.
Predictable, High-Quality Execution
Our team synthesizes clinical data, literature findings, and post-market evidence into clear, well-structured CER content, supported by structured quality and consistency reviews to support regulatory review readiness.
Turning Clinical Evidence into Regulatory Documentation
We translate complex clinical data into clear, defensible regulatory narratives that support the demonstration of safety and performance and inform benefit-risk conclusions across the device lifecycle.
Are You Ready for a Clinical Evaluation Report?
From initial CE marking through periodic updates and PMCF integration, MEDRA supports the
development of EU MDR 2017/745 compliant CERs that demonstrate clinical safety and
performance and support regulatory review in Europe.
Am I ready for an CER?
- Confirm device description, intended purpose, and classification are finalized
- Identify gaps in clinical data, literature evidence, or PMCF documentatio
When do I need a CER?
- MDD to MDR Transition: Legacy devices must update CERs to meet new EU MDR requirements
- Initial CE Marking: Required for all medical devices seeking EU market access under MDR
- Periodic Updates: CERs must be maintained and updated based on device class, PMCF findings, or significant changes
When do I need a CER?
- Support the demonstration of clinical safety and performance
- Inform benefit-risk determination in accordance with MEDDEV 2.7/1 Rev.4
- Address EU MDR Article 61 and Annex XIV clinical evidence requirements
