The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - commissioned a “Stud on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market". The study started in December 2022 and was performed over 14 months. It was contracted to a consortium led by the Austrian..