Consultation

The Enterprise Europe Network informs:
11.01.2024

The current legal framework for medical devices and in vitro diagnostic medical devices in the EU comprises two regulations adopted in April 2017: Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

The main objective of the European Commission is to identify the main benefits and challenges of the current governance structure in the medical device sector and its impact on innovation in order to inform possible adjustments to further optimize the system in the short, medium and long term.

With this in mind, the European Commission's Directorate-General for Health and Food Safety (DG SANTE) and the European Health and Digital Executive Agency (HaDEA), through Ernst&Young, are consulting companies on the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation.

The consultation is open until January 31, 2024. The survey language is English and submissions cannot be cached.

For more information and to access the survey, please visit here .

Source: European Commission