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.
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
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
Evnia offers a comprehensive RWE program which includes:
There are many ways to collect these real-world post-market data, and it is vital to be able to justify which approach(es) is optimal for a given medical device
The IMDRF defines a medical device registry as Organized system with a primary aim to improve the quality of patient care.
Clinical Experience data, published in peer reviewed journals, can provide a quick, compliant, and economical solution for your Clinical Data.
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.
Our clinical network of 128 clinical sites across Europe, including 18 hospitals, 92 diagnostic centres, 10 laboratories, 8 dental clinics, 1 international patient centre, 1 clinic of cosmetic dermatology and 1 IVF centre is lifting 2 key restraints of manufacturers:
The Evnia Clinical Network
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