The IMDRF defines a medical device registry as Organized system with a primary aim to improve the quality of patient care that continuously collects relevant data, evaluates meaningful outcomes, and comprehensively covers the population defined by exposure to particular device(s) at a reasonably generalizable scale (e.g., international, national, regional, and health system)
 Methodological Principles in the Use of International Medical Device Registry Data; IMDRF Patient Registries Working Group, March 2017: see it online
A medical device registry aims to collect RWD of effectiveness and safety of medical devices.
Medical associations may collect data on various devices used for procedures or conditions, as part of their clinical data registries. Medical device companies may also establish device-specific registries and use these data to support post-market surveillance and PMCF purposes.
There are 2 major types of registries:
Those can be utilised for several purposes including:
They are a source of data on the presence or occurrence of a particular disease or health-related individual characteristic(s), such as a set of signs or symptoms, or a specific condition of the monitored population
They are used to indicate a system of data collection by targeting patients exposed to a specific medical device. From a regulatory perspective, recruitment, and follow-up of these patients with the aim to evaluate the use, safety, effectiveness, or another outcome of this exposure typically corresponds to non-interventional, observational study in the targeted population.
Establishment of registries may be linked to various purposes and uses.
Registries are valuable tools for regulatory decision-making as they provide quantifiable real-world clinical data that can be customized to reflect either medical conditions or specific medical devices.
Under EU Regulation 2017/745, there are significantly increased requirements for the collection of RWD throughout the lifecycle of medical devices. In particular, EU Regulation 2017/745 requires that manufacturers who want to market/continue to market their MDs within Europe must develop and regularly update a process that will enable the monitoring of the real-world performance and safety of MDs, not only via the conduct of clinical investigations but also via the proactive, dynamic monitoring of feedback collected from patients, end-users, and healthcare professionals. These requirements are risk-based and part of a continuous process that updates the substantiative clinical evidence of clinical evaluation reports, aiming to confirm the positive benefit-risk ratio and the clinical benefit of any given MD.
Clinical Data Registries can be used to serve all the PMCF objectives,
A Clinical Data Registry used to support a PMCF program of a medical device or any other regulatory decision, must meet some standard requirements/features
At Evnia, we help MedTech and Biotech manufacturers develop, maintain and analyse registries and registries-based studies through a well-established program including
We enable our clients to leverage their real-world evidence for real-world regulatory purposes
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