In December 2022, the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - via the European Health and Digital Executive Agency (HaDEA) - contracted a “Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market” to a consortium led by the Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG), in collaboration with Areté, Agra CEAS Consulting IHS Markit (now part of S&P Global) and Civic Consulting. The study will run until February 2024.
The general objective of the study is to evaluate how the provisions established in Article 17 of Regulation (EU) 2017/745 on medical devices (MDR) have been implemented by EU Member States and how such provisions operate. For this purpose, the current market situation for reprocessing and reuse of single-use devices in Europe will be surveyed. The study uses a mixed-methods approach (literature review, data analysis and stakeholder involvement). A dashboard presenting the results and a final report will be prepared.
Working definitions of terms for the "Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market" (will be added soon)
One-pager about the study and its content
Should you have any questions, please do not hesitate to contact the Project Manager Friederike Windisch (firstname.lastname@example.org).