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 II”. The study, which started on 18 September 2025 and will end on 17 April 2026, 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.
Sub-task 1.4 of the MedPro II project presents an ‘Analysis on the impact of changes on requirements for the reprocessing of devices’. The sub-task is led by the Austrian National Public Health Institute and performed in collaboration with RAND Europe and Milieu.
Objective
Under Sub-Task 1.4, the study team will conduct an analysis to investigate the reprocessing of single-use devices (SUDs) conducted in accordance with Article 17 of the MDR, and compare costs, timelines and procedures with those for the reuse of surgical instruments (e.g. cleaning, disinfection, sterilization, maintenance and functional testing).
Consultation activities
To conduct the study appropriately, the study team will approach stakeholders for several consultation activities, including interviews and surveys.
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 report.
Survey with stakeholders
We kindly ask the following stakeholder groups to participate, and all representative associations and MedTech clusters to distribute the survey to their members and networks.
- Manufacturers / Reprocessors
- Healthcare providers and institutions
- Laboratories
- Sterilization units
Link to the survey: will be added on Monday, 9 March 2026
Survey deadline: 27 March 2026 (23:59 CET)
Endorsement Letter_HADEA_2025_SC_0038_10.11.2025.pdf
MedPro II_Task 1.4_HADEA_2025_SC_0038_DPN survey_final_25.11.2025.pdf
MedPro II_Task 1.4_HADEA_2025_SC_0038_DPN interviews_final_25.11.2025.pdf
Contact
Should you have any questions, please do not hesitate to contact the Project Manager Friederike Windisch (medical.devices@goeg.at).