CEP & CER Support
Clinical Evaluation Made Simple, Strategic, and Fully Compliant.
CEP & CER Service Offerings
Clinical Evaluation Plans (CEP)
- Reviewing current Clinical Evaluation Plans
- Updating plans according to new regulations
- Providing remediation strategies if gaps are found
Clinical Evaluation Reports (CER)
- Drafting and reviewing CERs
- Updating CERs with new data
- Addressing any gaps or compliance issues
- State-of-the-Art (SOTA) assessments
- Clinical claims mapping & benefit–risk analysis
Clinical Evaluation Plans (CEP) Offerings
We develop, review, and update CEPs to ensure alignment with MDR, MEDDEV 2.7/1 Rev.4, and relevant MDCG guidance.
CEP Review & Gap Assessment
Evaluation of existing Clinical Evaluation Plans against MDR requirements, including scope, objectives, and planned methodologies.
CEP Updates & Remediation
Updating Clinical Evaluation Plans based on new regulations, notified body feedback, or changes in device risk classification.
Structured Methodology Development
Includes literature search strategy, data appraisal techniques, clinical evidence identification, and PMS/PMCF integration.
End-to-End CEP Development
Covering Executive Summary, SOTA approach, Search Protocol, Data Appraisal, GSPR alignment, and PMS/PMCF strategy.
Clinical Evaluation Reports (CER) Offerings
We provide complete CER writing, updates, and remediation services—covering literature evaluation, clinical data analysis, SOTA, and benefit–risk assessment.
Drafting Full MDR-Compliant CERs
Including all mandatory sections: Executive Summary, SOTA, Clinical Evidence Literature, PMS Summary, Risk Management, and Conclusion.
CER Review, Updates & Remediation
Ensuring alignment with MDCG guidelines, addressing NB queries, and integrating new clinical, PMS, and complaint data.
Clinical Claims Mapping & Benefit–Risk Analysis
Mapping product claims with supporting clinical data and conducting structured benefit–risk assessments.
State-of-the-Art (SOTA) Assessments
Comprehensive landscape review of current clinical practices, alternative treatments, and minimum benchmark performance standards.
Evidence Synthesis & Literature Appraisal
Transparent screening, critical appraisal, and synthesis of clinical literature as per MEDDEV requirements.
CEP & CER Key Deliverables
Clinical Evaluation Plans (CEP)
Clinical Evaluation Reports (CER)
SOTA Reports
Literature Search Protocols
Critical Appraisal Tables & Evidence Summaries
Benefit–Risk Analysis
PMS & PMCF Linkage Sections
Reference Management (EndNote) & Citation Binder
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Contact Our MedTech Experts
Cetas Healthcare is the world’s leading boutique MedTech market research firm. We blend agency-grade research with strategic intelligence frameworks to track pipelines, regulatory shifts, clinical trials, and GTM strategies. As pioneers of ISO 14155-compliant PMCF surveys, we’ve managed 25,000+ patient case forms for Class II & III devices, helping clients secure CE certifications and stay ahead of EU MDR requirements.
Contact Us: communication@cetas-healthcare.com
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