January 17, 2024
The European Commission (EC) has rolled out a new data dashboard in an effort to provide more transparency in terms of medical device availability across European Union member states.
The European Commission (EC) engaged Gesundheit Österreich GmbH (Austrian National Public Health Institute) with Areté and Civic Consulting to collect data on the availability of medical devices. The study began in December 2022 and is expected to run for three years until the end of 2025.
This trio may be familiar as they have been described as involved in collecting data on notified body applications from the European Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR).
Organization of the dashboard
The EC dashboard is based on a Microsoft application, Power BI. It is organized into seven buttons: Home, About, Process Indicators, MDR Outcomes, IVDR Outcomes, Glossary/Links, and Contact/Help. The MDR and IVDR Outcomes pages have additional information buttons.
The dashboard is intended to present the data collected from the different stakeholders, to give an idea of the current availability of medical devices in the EU and the progression of transitions to the MDR and IVDR. The notified body survey data is one subset of data already being collected and analyzed.
Data already available on the dashboard
Data from the notified body survey can already be reviewed on the dashboard. This is available in the following buttons: Process Indicators, MDR Outcomes and IVDR Outcomes. In addition, different variables can be selected that present the data differently, or in different subsets of data. The MDR and IVDR Outcomes pages allow one to specify the date of the survey (2023): March, April, May, June and August.
It is important to note that the information does not likely present an accurate overview of the state of play. Although all stakeholders have been asked to provide input by completing several surveys, not all stakeholders were either able or willing to respond. Hence, we believe that the overview is not comprehensive: some would rather make progress with the transition to the new regulations.
The EC has shared their dashboard which presents the data collected on the availability of medical devices. While this certainly increases the transparency of some of this information, there is also a significant lag in the data’s availability. For example, only the survey data through August of the notified body survey has been released.
Emergo by UL will continue to monitor this data and support its clients with maintaining and obtaining market access, as it is a priority to work toward having sufficient medical devices available on the EU market.
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