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.

What We Do

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.

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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
Support in identifying appropriate data sources such as registries, observational studies, user
feedback, and post‑market data.
RWE Study Design Support
Structuring 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

When Do You Need a CER?