Clinical & Performance Evaluation
At Masuu Global Solutions, we deliver comprehensive Clinical and Performance Evaluation services for medical devices and in vitro diagnostics (IVDs), aligned with EU MDR 2017/745, EU IVDR 2017/746, and MEDDEV 2.7/1 Rev. 4.
Our scientific and regulatory experts conduct structured literature reviews, critical appraisals, and transparent evidence synthesis to produce Notified Body–ready documentation including CERs, PERs, CEPs, PEPs, SSCPs, SSPs, PMCF/PMPF Plans & Reports, PMSRs, PSURs, and more.
Every deliverable is methodologically sound, evidence rich, traceable, and designed to consistently withstand NB scrutiny across global markets.
Ensuring Compliance and Confidence Through Strong Clinical & Performance Evaluation
A well developed Clinical or Performance Evaluation is essential for:- Demonstrating safety, performance, and clinical benefit
- Supporting CE marking under MDR/IVDR
- Maintaining lifecycle compliance and post market obligations
- Substantiating product claims with state-of-the-art evidence
- Supporting global submissions
Under MDR and IVDR, evaluations are living documents, requiring continuous updates based on PMS, PMCF/PMPF, vigilance data, and current literature.
Common Challenges for Manufacturers
- Interpreting evolving MDR/IVDR guidance
- Addressing Notified Body comments
- Establishing an appropriate state-of-the-art baseline
- Managing complex literature and clinical data
- Maintaining traceability across evaluation steps
- Limited inhouse medical writing capacity
Masuu Global Solutions eliminates these challenges with a scientific, standardized, and transparent approach. Our evaluation methodologies, templates, and review processes are designed to meet the highest NB expectations—helping manufacturers achieve quicker approvals and long term compliance.
Masuu’s Clinical & Performance Evaluation Deliverables
Clinical Evaluation (EU MDR)
Clinical Evaluation Plan (CEP)
Outlines:- Evaluation scope
- Intended purpose & device claims
- Acceptance criteria
- Appraisal methodology and data strategy (Annex XIV)
Clinical Evaluation Report (CER)
Includes:- Device description & clinical background
- State of the art assessment
- Appraisal & analysis of clinical data
- Benefit–risk assessment
- Conclusions on safety & performance
Systematic Literature Review (SLR/LSR)
- Protocol driven
- Fully traceable search → screen → extract → appraise workflow
Summary of Safety and Clinical Performance (SSCP)
User facing summary aligned with MDR requirements.Performance Evaluation (EU IVDR)
Performance Evaluation Plan (PEP)
Covers:- Scientific validity
- Analytical performance
- Clinical performance
- Data sources and methodological approach
Performance Evaluation Report (PER)
A comprehensive evidence synthesis referencing:- Scientific Validity Report (SVR)
- Analytical Performance Report (APR)
- Clinical Performance Report (CPR)
- State of the art
- Benefit–risk evaluation
- Linkage with PMPF
SVR / APR / CPR
Standalone or integrated components feeding the PER and Technical Documentation.Systematic Literature Review (SLR/LSR)
Fully protocolized and traceable per IVDR methodology.Summary of Safety and Performance (SSP)
Aligned with IVDR obligations and intended user groups.Post Market & Lifecycle Documentation
- PMS Plans (PMSP)
- PMS Reports (PMSR)
- PSURs
- PMCF & PMPF Plans and Reports
- Continuous updates based on signals, new data, and market feedback
- Gap analyses & remediation to maintain living documents
Technical Documentation & Submission Support
- Aligning CER/PER outcomes with Technical Documentation
- Preparing SSCPs
- Supporting Notified Body responses and clarification cycles
- Assistance with U.S. submissions where relevant
Masuu’s Clinical & Performance Evaluation Service Suite
- Clinical Evaluation
- Performance Evaluation
- Lifecycle Management
- Literature Search Protocol & Review
Why Partner With Masuu Global Solutions?
- Demonstrated MDR/IVDR expertise with deep familiarity with Annex XIV & Annex XIII
- NBready documentation built through strict internal quality checks
- End to end capability—from planning to post market updates
- Automated literature search and evidence management tools
- Standardized, transparent processes ensuring accuracy and traceability
- Global regulatory reach across EU, UK, US, and APAC markets
- Faster turnaround times without compromising scientific integrity