Medical devices (MD) and in vitro diagnostic medical devices (IVD) are essential for a working healthcare system and have a crucial role to play in the prevention, diagnosis, monitoring, prediction, prognosis and treatment of acute and chronic illness and diseases as well as rehabilitation.
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) are fully applicable
by 26 May 2021 and 26 May 2023, respectively. They aim to improve the quality, safety and reliability of medical devices, strengthen transparency and information for patients and enhance vigilance and market surveillance.
Both Regulations provide for transitional periods during which devices that are in conformity with the previous Directives can still be placed on the EU
market. In case of medical devices this is also subject to specific conditions.
In order to ensure a smooth transitioning, it is essential to regularly apprise the situation on the ground and gather concrete data on the activities
currently performed by relevant stakeholders.
A study was commissioned by the European Commission (via its European Health and Digital Executive Agency / HaDEA) from Gesundheit Österreich GmbH (Austrian National Public Health Institute), Civic Consulting and Areté supported by experts from the medical devices sector to monitor
the availability of medical devices on the EU market.
The study will last 36 months starting from December 2022, examining the context of the implementation of regulations for medical devices and contributing to identify potential challenges to be addressed as well as possible solutions.