The Pharmacoeconomics Department is conducting two studies in the field of medical devices:
1) Study supporting the monitoring of availability of medical devices on the EU market
A consortium led by the Austrian National Public Health Institute (Gesundheit Österreich GmbH/GÖG), in collaboration with Areté and Civic Consulting, has been commissioned by the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) – to conduct a “Study supporting the monitoring of availability of medical devices on the EU market”. The study started in December 2022 and will be running for 36 months (December 2025).
The general objective of the study is to monitor and analyse the availability of medical devices on the EU market in the context of the implementation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. For this purpose, relevant stakeholders will be mapped and consulted, and information needs as well as data sources will be identified. The study team will also design and establish a dashboard to gather the data retrieved and, based on feedback received, identify obstacles that could affect availability of devices and/or impair the conformity assessment process, pointing to potential solutions.
More information: https://ppri.goeg.at/Study_MD_Availability
2) Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market
The Austrian National Public Health Institute (Gesundheit Österreich GmbH/GÖG), in collaboration with Agra CEAS Consulting (S&P Global), Areté and Civic Consulting, has been commissioned by the European Commission (via the European Health and Digital Executive Agency / HaDEA) to conduct a study on the implementation of Article 17 (single-use devices and their reprocessing) of Regulation (EU) 2017/745 on medical devices on the EU market.
The main objective of the study is to evaluate how the provisions established in Article 17 of the 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 (EU Member States and other countries) will be presented.
The study started in December 2022 and will be carried out over 14 months.
More information: https://ppri.goeg.at/Study_Article17MDR
Last update: 21 June 2023