EU MDR–compliant Clinical Evaluation Report (CER) services for medical devices. Literature, equivalence, PMCF & NB-ready CERs by Bioexcel.
Clinical Evaluation Report (CER) Services For Medical Devices
Bioexcel provides EU MDR–compliant Clinical Evaluation Report (CER) services to support CE marking and lifecycle compliance for medical devices. Our CERs are prepared in alignment with MDR Annex XIV, MEDDEV legacy principles, and current Notified Body expectations.
What Is a Clinical Evaluation Report (CER)
A Clinical Evaluation Report (CER) is a mandatory regulatory document under EU MDR that demonstrates the clinical safety, performance, and benefit-risk profile of a medical device throughout its lifecycle.
Bioexcel develops CERs that are:
- Scientifically robust
- Evidence-based
- Defensible during Notified Body review
Our CER Capabilities
We support new, legacy, and high-risk medical devices across all MDR classes.
CER Services Include:
- Clinical Evaluation Plan (CEP) development
- Systematic literature review (SLR)
- State-of-the-art (SoTA) analysis
- Clinical data appraisal & weighting
- Equivalence assessment (technical, biological, clinical)
- Benefit-risk analysis
- MDR Annex XIV–compliant CER drafting
- CER updates & remediation for NB findings
EU MDR & Regulatory Alignment
All CERs are aligned with:
- EU MDR (Regulation (EU) 2017/745)
- MDR Annex XIV – Part A
- MDCG guidance documents
- Notified Body best practices
Our CERs are structured to minimize NB questions and reduce review cycles.
CER, PMCF & Real-World Evidence Linkage (CRITICAL)
Bioexcel ensures strong integration between:
- CER ↔ PMCF Plans & Reports
- CER ↔ Real-World Evidence (RWE)
- CER ↔ Clinical Investigation data
- Continuous clinical evidence generation
- Long-term MDR compliance
- Audit-ready documentation
Technology-Enabled CER Development (VigiX™ + Xceltrials™)
We leverage Bioexcel's digital platforms to enhance CER quality and traceability:
- VigiX™ — PMS & PMCF data integration, complaint and trend analysis, post-market clinical evidence linkage
- Xceltrials™ — structured clinical data management, evidence traceability, audit-ready documentation
- CE marking under EU MDR
- Legacy device MDR transition
- NB non-conformity remediation
- Significant design or intended-use changes
- Periodic CER updates
Why Bioexcel for CER Services?
- Dedicated medical device & IVD focus
- Deep expertise in MDR clinical evaluation
- Strong NB-facing documentation approach
- Seamless integration with PMCF, PMS & digital tools
- Periodic CER updates
Clinical Evaluation Report (CER) Services | EU MDR | Bioexcel
EU MDR–compliant Clinical Evaluation Report (CER) services for medical devices. Literature, equivalence, PMCF & NB-ready CERs by Bioexcel.