Use of Registries for Regulatory Purposes
Clinical Data from Registries is a requirement to be considered and appraised by medical device manufacturers according to the applicable regulatory documents.
In the European Union this requirement was first introduced by Guidance MEDDEV 2.7/1 rev 4, applicable from June 2016 https://ec.europa.eu/docsroom/ and enforced by the new Medical Device Regulation https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
Although this requirement will have a significant impact on the use of clinical data and a large variety of processes of manufacturers and regulators, the term of “Register” is not defined in EU documents. This is explicable since in parallel to the development of the MDR the topic of “clinical data from registries” was subject to global harmonization by the IMDRF.
Between 2016 and 2018 the “IMDRF Patient Registries Working Group” published threedocuments on this subject http://www.imdrf.org/documents/documents.asp
The globally accepted definition of “Register” or “Registry” has been elaborated by the AHRQ.
Accordingly, a medical device registry is defined as an
“Organized system with a primary aim to increase the knowledge on medical devices contributing 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)”.
This is a rather general definition and includes any structured data collection without a defined termination. Defining the end of data collection is the main distinctive feature as compared to sample-based clinical studies.
The AHRQ definition includes any structured data collection in the health care system related to a medical device such as
- Quality Registries as implemented successfully in many countries for decades „Links“
- Routine data collection in hospitals and by other stakeholders in the health care system
- Data processed and collected by active medical devices and apps
- Data collected by telemedicine and similar activities
- Structured market surveillance feedback like surveys Quality Registries are high-end options in this spectrum since they provide well-structured data collection and evaluation processes. For other data sources these efforts have to be undertaken as part of the project organisation and assessment procedures by the manufacturer. From a regulatory perspective registries are service providers, and manufacturers need to monitor quality in similar processes as conducted by any other service provider or subcontractor (i.e. written evidence on processes and audits or certificates by independent entities). For registries this requires additional efforts in the documentation of standard processes and on-demand evaluations, similar to “Material and Methods” in published articles.
The third IMDRF document provides detailed information on categories regulators request for transparency and reproducibility.
As the new MDR requires more stringent links between clinical data and risk management/quality management, it appears very likely that this will lead to “Industry 4.0” processes with manufacturers.
Similar to other business fields opportunities opened up by increased IT-based documentation can and shall be realized. This requires harmonization of the way real-world evidence data are collected, evaluated and delivered to manufacturers and authorities as well as harmonization of the way these data shall be processed by companies within the given legal framework.
There are best-practice models already established in other business fields, like aviation, automotive or retail, that need to be adapted to the medical device industry and the needs of individual companies and devices.
Some more information on requirements by MDR on a global perspective is available in a short YouTube video.