During the last decade, a significant focus towards RWE utilisation as means of objective evidence for medical device performance and safety is constructed within regulatory frameworks. Introduction of the new European Regulations (EU/MDR) has further intensified the efforts to incorporate RWD into the cluster of clinical data sources used to support regulatory decision-making since post-market surveillance requirements practically necessitates it.
Even though definition of terms is not identical among regulators, the sources of data and the intend of data and clinical evidence utilisation to support performance and safety is a constant theme.
Summary of Sources of data
Key factors to consider in evaluating RWE and RWD
Whether the RWD are fit for use in medical device regulatory decision-making
Whether the study design used to generate RWE can provide adequate scientific evidence to help answer the regulatory question
Whether the study conduct meets regulatory requirements (for example, for monitoring and data collection)
RWD can be collected at all stages of the lifecycle of a medical device, from pre-market clinical investigations (CIs) to post-market surveillance (PMS) of real-world usage of the device. As such, it is not only used to establish the safety and performance of a device before market-release, but also to ensure a sufficient level of post-market surveillance.
Therefore, collection of RWD is a pillar of compliant PMCF programs since, they can be used as input to serve all PMCF objectives, i.e., to
Proactively collect and evaluate clinical data from the use in or on humans
Confirm the clinical safety and performance of a medical device throughout its expected lifetime
Ensure the continued acceptability of identified risks
Detect emerging risks on the basis of factual evidence
Major challenges associated with RWE
There are ongoing, international efforts to establish common frameworks for the use of RWD/RWE for regulatory purposes highlighting the need to leverage RWE throughout the lifecycle of medical devices.
However, there are global limitations to the use of RWE include the collection, such as
Lack of international harmonization & different requirements per country/region
Lack of standardization, best practices, and reporting standards
Challenges related to data sources: quality, validity, and collection process of the data: difficulty to collect consistent, accurate and timely data
Lack of data validation
Why choose RWE over traditional clinical trials to support your PMCF activities?
Collection of RWE is a cost-saving PMCF option especially for legacy devices
RWE can serve all PMCF objectives at once
Reflection of real-world clinical practice is an efficient and dynamic monitoring option identifying
Depending on study design, RWD can be adjusted to meet device-specific needs regardless of device class
How Can Evnia help?
Evnia offers a comprehensive RWE program which includes:
Our in-house team of clinical experts and medical writers will evaluate your CER conclusions, will perform a clinical evidence gap analysis and will determine the optimal PMCF strategy for your product portfolio proposing one or more PMCF activities depending on classification and regulatory status.