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

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation - MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article. This study evaluates how the provisions established in Article 17 MDR have been implemented and how such provisions function in practice. For this purpose, the current market situation for the reprocessing and reuse of SUDs was surveyed and analysed across 30 European countries (EU-27 plus Iceland, Liechtenstein and Norway). This report presents an overview of national decisions regarding the reprocessing of SUDs in the countries studied (ranging from permitted to prohibited to no decision taken at all). The study also reports on the certification processes for SUDs by notified bodies, the reprocessing of SUDs by manufacturers and health institutions and the reuse of purchased reprocessed SUDs by health institutions. Perceived challenges and opportunities as well as actions recommended by stakeholders are included as well. The report closes with a series of conclusions and recommendations for optimising the implementation of Article 17 MDR in Europe.