IVDR-compliant Performance Evaluation Report (PER) services for IVDs covering scientific validity, analytical and clinical performance.
Performance Evaluation Report (PER) Services For IVDs
Bioexcel provides IVDR-compliant Performance Evaluation Report (PER) services for in vitro diagnostic medical devices (IVDs). Our PERs are developed in alignment with IVDR Annex XIII, supporting conformity assessment, Notified Body review, and lifecycle compliance.
What Is a Performance Evaluation Report (PER)?
Under the EU IVDR (Regulation (EU) 2017/746), a Performance Evaluation Report (PER) is a mandatory document demonstrating that an IVD achieves its intended purpose through:
- Scientific validity
- Analytical performance
- Clinical performance
Bioexcel prepares PERs that are structured, traceable, and defensible during Notified Body assessment.
Our IVDR Performance Evaluation Capabilities
We support all IVD risk classes, including Class B, C, and D devices.
PER Services Include:
- Performance Evaluation Plan (PEP) development
- Scientific validity assessment (clinical association)
- Analytical performance evaluation review
- Clinical performance evaluation strategy
- Performance study gap analysis
- IVDR Annex XIII–compliant PER drafting
- PER updates and NB remediation support
IVDR & Regulatory Alignment
All PER activities are aligned with:
- EU IVDR (Regulation (EU) 2017/746)
- IVDR Annex XIII – Performance Evaluation
- MDCG guidance documents
- Notified Body expectations for IVDs
Our approach ensures clear traceability between evidence and performance claims.
Performance Evaluation, PMS & Real-World Evidence Linkage
Bioexcel integrates PER development with ongoing post-market and real-world evidence activities to ensure continuous compliance.
- PER ↔ PMS & PMPF (Post-Market Performance Follow-up)
- PER ↔ Real-World Evidence (RWE)
- PER ↔ Performance studies (where applicable)
- PMCF & PMS Services
- Real-World Evidence (RWE)
Technology-Enabled PER Development
VigiX™
- Post-market data integration
- Signal detection and trend support for IVDs
- Xceltrials™ — Structured capture of performance study data
- Evidence traceability across reports
- IVDR conformity assessment
- Transition from IVDD to IVDR
- New IVD product launches
- Significant changes to intended purpose
- Notified Body nonconformity remediation
Why Bioexcel for IVDR PER Services?
- Dedicated focus on IVDs & IVDR compliance
- Strong understanding of NB performance evaluation expectations
- Seamless integration with PMS, PMPF & RWE
- Audit-ready documentation and structured evidence
Performance Evaluation Report (PER) Services | IVDR | Bioexcel
IVDR-compliant Performance Evaluation Report (PER) services for IVDs covering scientific validity, analytical and clinical performance.