Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market

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.

Objective

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.

Glossary

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"

One-pager about the study and its content

One-pager short version

One-pager long version

Final report

Windisch F, Zimmermann N, Knoll V et al. (2024): Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market. Final report. Publications Office of the European Union. https://data.europa.eu/doi/10.2925/210943  

Dashboard

Link to the study-related dashboard

Contact

Should you have any questions, please do not hesitate to contact the Project Manager Friederike Windisch (medical.devices@goeg.at).