,Ensuring Compliance and Confidence Through Robust Clinical and Performance Evaluations
Accurate and well-structured Clinical and Performance Evaluations are essential to demonstrate the safety, performance, and clinical benefit of medical devices and IVDs. Under EU MDR 2017/745 and IVDR 2017/746, manufacturers must maintain robust, evidence-based documentation that reflects the current state-of-the-art, validates product claims, and ensures patient safety. A compliant Clinical Evaluation Report (CER) or Performance Evaluation Report (PER) is no longer a one-time regulatory deliverable, it is a living, evolving document central to lifecycle management and global market access.
However, many manufacturers face common challenges, such as interpreting evolving regulatory expectations and Notified Body feedback, establishing clear state-of-the-art benchmarks and evaluation criteria, managing extensive literature, clinical, and post-marketing data, ensuring methodological transparency and traceability and limited in-house expertise and resource constraints often lead to delayed approvals, major non-conformities, or repeated Notified Body queries.
At Freyr, we bridge these gaps with a proven, methodology-driven approach that combines regulatory and scientific expertise, standardized and Notified Body-approved templates, and automated literature review tools. Our specialists ensure each evaluation is transparent, comprehensive, scientifically justified, and aligned with the latest state-of-the-art and MDR/IVDR guidance, empowering manufacturers to achieve faster, NB-ready submissions and maintain ongoing compliance with confidence. Partner with Freyr to strengthen your Clinical and Performance Evaluation strategy, ensuring compliance, credibility, and sustained global market success.
Our Clinical and Performance Evaluation Deliverables
Clinical Evaluation (EU MDR)
- Clinical Evaluation Plan (CEP): Defines scope, device claims, acceptance criteria, and appraisal methods aligned with Annex XIV.
- Clinical Evaluation Report (CER): Includes device description, state-of-the-art assessment, clinical data synthesis, critical appraisal, benefit–risk evaluation, and conclusions.
- Systematic Literature Reviews (SLR/LSR): Protocol-driven search, screening, extraction, appraisal with full traceability.
- SSCP (as applicable): User-facing summaries aligned with MDR requirements.
Performance Evaluation (EU IVDR)
- Performance Evaluation Plan (PEP): Strategy covering scientific validity, analytical and clinical performance.
- Performance Evaluation Report (PER): Consolidated evaluation referencing SVR/APR/CPR, state-of-the-art, benefit–risk assessment, and linkages to PMPF, per Annex XIII.
- SVR/APR/CPR: Standalone or integrated reports feeding the PER and technical documentation.
- Systematic Literature Reviews (SLR/LSR): Protocol-driven search, screening, extraction, appraisal with full traceability.
- SSP (as applicable): User-facing summaries aligned with IVDR requirements
Post-market & Lifecycle Documents
- PMS Plan (PMSP)/PMS Report (PMSR), PSUR and PMCF/PMPF: Plans & reports tied back to CER/PER for continuous conformity.
- Gap Analysis and Remediation-Maintenance updates: Updates for living documents (signals, changes, new evidence).
Technical Documentation & Submissions
- Mapping CER/PER outputs to Technical Documentation (EU) and supporting US submissions where relevant.
- Preparation of SSCP and targeted NB responses.
Freyr's Clinical & Performance Evaluation Services
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Why Partner with Freyr?
- Proven MDR/IVDR expertise delivering compliant CERs and PERs aligned with MEDDEV 2.7/1 Rev. 4, Annex XIV, and Annex XIII.
- NB-ready documentation developed through rigorous internal QA to minimize Notified Body queries and ensure first-time approval.
- End-to-end capability covering scoping, literature review, authoring, submission, and post-market updates for complete compliance.
- Automation-driven processes and standardized templates ensuring accuracy, traceability, and faster turnaround times.
- Global regulatory reach supporting device and IVD manufacturers across EU, US, UK, and Asia for seamless market access.
Frequently Asked Questions (FAQs) on Clinical & Performance Evaluation
We are here to provide you with the information you need quickly and efficiently.
01. What is a Clinical Evaluation Report (CER) and why is it critical under EU MDR?
A CER documents the clinical evaluation process for a medical device—identifying, appraising, and analysing clinical data to demonstrate safety and performance. Under EU MDR 2017/745, it’s a mandatory, living document that substantiates compliance with General Safety and Performance Requirements (GSPRs) and is essential for CE Marking and Notified Body review.
02. When should a Performance Evaluation Report (PER) be prepared under IVDR?
A PER must be prepared for every IVD under EU IVDR 2017/746 to demonstrate scientific validity, analytical performance, and clinical performance. It’s developed in accordance with a Performance Evaluation Plan (PEP) and maintained throughout the product lifecycle using PMPF and PMS data to ensure continued regulatory conformity.
03. How often should CERs or PERs be updated?
CERs and PERs are living documents that must be updated whenever significant new data emerges—such as new clinical evidence, changes in the state-of-the-art, or new post-market findings. Regular updates, usually aligned with PMS or PMCF cycles, are crucial to maintain ongoing MDR/IVDR compliance.
04. What role does “state-of-the-art” (SOTA) play in evaluation documentation?
“State-of-the-art” defines the current scientific and technological benchmark for evaluating device safety and performance. It guides literature searches, equivalence claims, and benefit-risk analysis, ensuring the device meets or exceeds accepted standards. Regulators assess conformity based on how well a manufacturer positions their device within this evolving context.
05. What is the role of a Systematic Literature Review (SLR) in CERs and PERs?
An SLR provides the structured, reproducible method for gathering and analyzing published evidence on device safety, performance, and clinical outcomes. It ensures transparency, minimizes bias, and establishes the state-of-the-art baseline. Regulators view SLRs as a cornerstone of defensible CER and PER submissions under MDR and IVDR.
06. Do manufacturers always need to conduct new clinical investigations for CER/PER?
Not necessarily. When sufficient high-quality literature, equivalence, or post-market data exist, new clinical investigations may not be required. However, all evidence must be critically appraised, traceable, and justified against MDR/IVDR standards to confirm the device’s safety and performance.
07. What are common pitfalls that lead to Notified Body queries in CER/PER submissions?
Typical issues include inadequate literature search methodology, missing state-of-the-art justification, poor data traceability, weak benefit-risk conclusions, and lack of clarity in equivalence rationale. Addressing these early with structured templates and transparent methodology minimizes Notified Body queries and accelerates compliance review.
08. Why is Freyr considered a leading partner for Clinical and Performance Evaluation services?
Freyr combines deep MDR/IVDR regulatory expertise, structured methodologies, and proven NB-ready documentation practices to deliver compliant CERs, PERs, and supporting reports with unmatched precision. Our integrated approach, spanning literature review automation, SME-led analysis, and lifecycle updates, positions Freyr among the most trusted global partners for Clinical and Performance Evaluation excellence.
