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
Frequently Asked Questions
A Clinical Evaluation Report (CER) is a structured assessment of clinical data used to demonstrate a medical device’s safety, performance, and clinical benefit under EU MDR. It evaluates relevant evidence, the state of the art, clinical data, benefit-risk considerations, and conclusions supporting the device’s intended purpose and claims.
A CER is used for medical devices under EU MDR and focuses on clinical evidence supporting safety, performance, and clinical benefit. A PER is used for IVDs under EU IVDR and integrates evidence covering scientific validity, analytical performance, and clinical performance. Both support regulatory compliance but apply to different product categories.
A Clinical Evaluation Plan defines how the clinical evaluation will be conducted and documented. It typically establishes the evaluation scope, intended purpose, device claims, evidence requirements, acceptance criteria, data sources, and appraisal methodology. Under EU MDR, the clinical evaluation approach should align with applicable Annex XIV requirements.
Evidence for an MDR clinical evaluation can include relevant clinical data, scientific literature, clinical investigation results, post-market data, and information related to comparable devices where applicable. The evidence should support the device’s intended purpose, safety, performance, and clinical benefit and should be critically appraised for relevance and quality.
A Performance Evaluation Plan (PEP) defines the methodology and evidence strategy for evaluating an IVD under EU IVDR. It addresses scientific validity, analytical performance, and clinical performance, including the data sources, evaluation methods, acceptance criteria, and approach used to establish the evidence supporting the IVD’s intended purpose.
An IVDR Performance Evaluation Report can integrate evidence from scientific validity, analytical performance, and clinical performance assessments. Supporting documentation may include Scientific Validity Reports, Analytical Performance Reports, and Clinical Performance Reports, together with state-of-the-art assessment, benefit-risk evaluation, and appropriate linkage to post-market performance follow-up.
Literature review is an important component of clinical and performance evaluation when relevant published evidence is needed to support the assessment. A systematic, protocol-driven process should define the search, screening, data extraction, and critical appraisal methods. The resulting evidence should be traceable and relevant to the device and intended purpose.
Clinical and performance evaluations are treated as living documents under MDR and IVDR. Updates should incorporate relevant new clinical or performance evidence, current literature, PMS findings, PMCF or PMPF data, vigilance information, and other safety or performance signals. The frequency and scope of updates should reflect the device and available new evidence.
PMCF under MDR and PMPF under IVDR generate additional post-market evidence about a device’s clinical or performance characteristics. Their findings can feed into ongoing clinical or performance evaluations, PMS documentation, and regulatory assessments. New data may require updates to CERs, PERs, benefit-risk assessments, and supporting technical documentation.
A CER or PER should use a transparent, traceable, and scientifically justified methodology. It should clearly connect the intended purpose and claims with the evidence, state of the art, appraisal methods, safety and performance conclusions, and benefit-risk assessment. Supporting documentation should remain consistent with the technical file and post-market evidence.