Real World Evidence (RWE) is clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of Real World Data (RWD).
RWE has become increasingly important following the implementation of the Medical Device Regulation (MDR 2017/745), fully implemented from May 2021. Medical device manufacturers are required to develop and implement a Clinical Evidence Generation system that generates real-world data on device safety and performance while remaining in compliance with all relevant legislation.
Data derived from patient medical records and clinical documentation systems.
Claims and billing information that provide insights into device usage patterns.
Structured databases tracking device implants and patient outcomes over time.
Data collected from home-use settings and mobile devices for continuous monitoring.
Understanding the key differences between Real World Evidence and traditional clinical investigations.
| Aspect | Real World Evidence (RWE) | Traditional Clinical Trial |
|---|---|---|
| Patient Population | Diverse, real-world population with varied characteristics and comorbidities | Restrictive eligibility criteria ensuring specific patient characteristics |
| Setting | Routine clinical practice in real-world healthcare settings | Controlled research environment with standardized protocols |
| Data Collection | Observational, non-interventional data collection | Prospective data collection with active monitoring |
| Duration | Flexible, often longer-term follow-up (months to years) | Fixed duration, typically shorter (weeks to months) |
| Regulatory Burden | Light regulatory burden; no ethics committee approval required if routine practice | Heavy regulatory burden; requires ethics committee and competent authority approval |
| Long-term Data | Provides medium to long-term safety and performance data | Limited long-term data; extrapolation often required |
| Cost | Generally lower cost due to use of existing data sources | Higher cost due to intensive monitoring and control requirements |
Real World Evidence collection is a powerful approach to fulfill Post-Market Clinical Follow-up (PMCF) requirements under the EU MDR while generating robust, long-term safety and performance data.
Continuously track adverse events and safety signals in real-world patient populations over extended periods.
Evaluate device performance across diverse patient populations and clinical settings beyond pre-market trial conditions.
Gather medium to long-term outcome data (months to years) to validate implant longevity and durability claims.
Generate evidence that meets EU MDR requirements for clinical evaluation and notified body expectations.
Compare device outcomes with predicate devices or standard-of-care treatments in real-world settings.
Identify and manage potential risks early through systematic data collection and analysis.
At Eclevar MedTech, we conduct a comprehensive feasibility study before engaging in any RWE clinical study. This ensures the quality and quantity of data sources are sufficient for your intended use. We understand that the advantages of RWE are only realized with reliable, high-quality data.
Evaluate data source quality, completeness, and consistency across investigational centers.
Design a robust RWE study protocol aligned with ISO 14155:2020, GCP, and regulatory requirements.
Systematically collect real-world data from hospital networks, registries, and clinical settings.
Perform rigorous statistical analysis to generate clinically meaningful evidence on safety and performance.
Deliver comprehensive PMCF reports and Clinical Evaluation Reports (CER) for regulatory submission.
Data quality encompasses completeness, consistency, and accuracy across all investigational centers. Our rigorous quality assurance processes ensure that every data point meets our high standards before analysis.
A comprehensive RWE multicentre study demonstrating how we generated robust clinical evidence for a vascular prosthesis under EU MDR requirements.
Vascular prostheses made of knitted polyester fabrics in straight tubular shapes, impregnated with ultra-purified collagen of bovine origin. Indicated for replacement or bypass of arteries damaged by aneurysm or arterial occlusive disease.
The Clinical Evaluation Report showed that intended claims on clinical safety and performance were not sufficiently supported by existing clinical evidence. To maintain market authorization in Europe, a comprehensive PMCF study was required to generate sufficient clinical data in compliance with EU MDR Chapter VI (sections 62-82) and ISO 14155:2020.
Study Type: Multicentre RWE study with retrospective and prospective data collection from medical charts.
Patient Population: 250-300 subjects evaluated across 3-8 hospital sites.
Anatomical Coverage: Minimum 100 subjects in carotid location, minimum 100 in femoral location.
Follow-up Duration: From baseline (time of surgery) to maximum 3 years post-surgery.
Comprehensive adverse event tracking across 250-300 patients over 3 years.
Device performance validated in diverse patient populations and clinical settings.
Evidence met EU MDR requirements and notified body expectations for CE certification.
3-year follow-up data validated implant longevity and durability claims.
Robust evidence strengthened market position and customer confidence.
Performance data across different anatomical locations (carotid vs femoral).
Real World Evidence collection is governed by strict regulatory requirements across Europe. Understanding the specific requirements for your target market is essential for successful PMCF implementation and regulatory approval.
Regulation: EU MDR 2017/745
Key Requirements:
Applies to all EU Member States
Competent Authority: ANSM (National Agency for Safety of Medicines)
Key Requirements:
Strong hospital infrastructure for RWE studies
Competent Authority: BfArM (Federal Institute for Drugs)
Key Requirements:
Rigorous regulatory oversight and quality standards
Competent Authority: MHRA (Medicines & Healthcare Products Regulatory Agency)
Key Requirements:
Well-established NHS network for clinical data
Comprehensive documentation is essential for regulatory approval and successful study execution. We prepare all required documentation to meet regulatory expectations across all target markets.
Established relationships with leading hospitals across France, Germany, and UK
Deep knowledge of EU MDR, national requirements, and notified body expectations
Rigorous quality assurance processes ensure high-quality, compliant data collection
Streamlined processes reduce study timelines without compromising quality
Full GDPR, GCP, and ISO 14155:2020 compliance across all study activities
Proven track record of generating evidence that meets regulatory approval standards
Let's discuss how our RWE expertise can support your medical device's regulatory strategy and market success.
