Real-world evidence services for medical devices and IVDs supporting MDR/IVDR clinical evaluation, PMS, PMCF and lifecycle compliance.
Real-World Evidence (RWE) For Medical Devices & IVDs
Under EU MDR and IVDR, manufacturers are increasingly expected to use real-world data to support continuous clinical evaluation, post-market surveillance, and benefit–risk assessment.
Bioexcel supports the planning, collection, structuring, and interpretation of Real-World Evidence (RWE) to strengthen lifecycle clinical evidence in a regulator-aligned manner.
What Is Real-World Evidence in Medical Devices?
Real-World Evidence refers to clinical evidence derived from real-world data (RWD) generated during routine use of a medical device or IVD outside traditional clinical trials. Under MDR and IVDR, RWE may complement clinical investigations, literature-based evidence, post-market surveillance and PMCF activities.
Our Real-World Evidence Capabilities
- RWE Strategy & Planning — defining RWE objectives aligned with clinical evaluation, PMCF, or performance evaluation needs
- Real-World Data Source Identification — registries, observational studies, user feedback, and post-market data
- RWE Study Design Support — observational and non-interventional study designs aligned with ISO 14155 principles (where applicable)
- Data Structuring & Documentation — organizing RWE outputs for traceability into CER, PER, PMSR, or PSUR
- Lifecycle Evidence Integration — linking RWE outputs with PMS, PMCF, risk management, and clinical evaluation updates
Use of RWE Across the Product Lifecycle
Real-World Evidence may support:
- Clinical Evaluation (CER) updates under MDR
- Performance Evaluation (PER) for IVDs under IVDR
- PMCF activities and residual risk confirmation
- Post-market surveillance trending
- Benefit–risk assessment updates
- Legacy devices transitioning to MDR
- Devices with extensive post-market use
- Supporting equivalence-based clinical evaluation
- Addressing Notified Body questions on real-world performance
- Supplementing PMCF outcomes
Frequently Asked Questions (FAQ)
Real-World Evidence
Real-World Evidence (RWE) For Medical Devices & IVDs | MDR & IVDR | Bioexcel
Real-world evidence services for medical devices and IVDs supporting MDR/IVDR clinical evaluation, PMS, PMCF and lifecycle compliance.