The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - has commissioned a study on “Analyses on markets of medical devices and of medicinal products – MedPro I”.
The study, which started on 3 June 2025 and will end on 16 December 2025, has been contracted to a consortium led by Technopolis, in collaboration with the Austrian National Public Health Institute (Gesundheit Österreich Beratungs GmbH/GÖ B), IQVIA and PredictBy.
Objective
Under Sub-Task 1.1, which is led by the Austrian National Public Health Institute, the study team will conduct an analysis of the medical device supply chain and shortage management in the EU. The analysis involves defining medical device availability issues and shortages, mapping supply chain dependencies on third countries, and analysing root causes of shortages with a focus on industrial/non-regulatory factors. The study team will examine existing governance structures at the EU level and in other jurisdictions for managing shortages and will develop a methodology for identifying critical medical devices. Based on the evidence, solutions to enhance supply chain resilience will be proposed and their feasibility and impact will be analysed. This analysis aims to support ongoing efforts to address medical device availability challenges in the EU.
Consultation activities
To conduct the study appropriately, the study team will approach stakeholders (e.g. regulatory authorities, industry representatives, healthcare providers) for several consultation activities, including interviews, a survey and a workshop.
Acting in full compliance with EU competition law, and within its limits, the study team will keep any specific information (raw data) collected at the individual level strictly confidential and under no circumstances will individualised information be disclosed. The study team will ensure that the data is handled with the utmost care and protection. Only aggregated survey outcomes will be published and included in the final reports.
Survey with stakeholders
Information on the survey launch: to be added
Endorsement Letter_HADEA2024_OP_0029_16.7.2025_signed.pdf
Contact
Should you have any questions, please do not hesitate to contact the Project Manager Friederike Windisch (medical.devices@goeg.at).