Tuttlingen/Brussels - SMEs in particular are asked to participate by January 31st: On behalf of the European Commission, the consulting firm Ernst and Young (EY) is conducting a survey on how the governance structure in the medical device sector is assessed and impacts innovations. MedicalMountains GmbH belongs to the Advisory Group.
The survey is an essential part of the “Study on Regulatory Governance and Innovation in the field of Medical Devices” about the development of the regulatory environment after the introduction of the MDR and IVDR. The consulting firm EY was entrusted with the preparation by the Directorate-General for Health and Food Safety of the European Commission (DG SANTE) and the European Executive Agency for Health and Digital Affairs (HaDEA). The European Commission states that the main objective is to identify the main advantages and challenges of the current governance structure in the medical devices sector and their impact on innovation, in order to identify possible needs for adaptation in the short, medium and long term. Julia Steckeler from MedicalMountains GmbH has been invited, along with 15 other members from Europe, to accompany the study as a member of the Advisory Group. Its completion is expected at the end of 2024.
Given the importance of the study for political decision-making, DG SANTE and HaDEA encourage active participation in the survey, which can be accessed via this link. Depending on the number of questions to be answered, it takes 20 to around 40 minutes. Further explanations of the survey and a general overview of all questions can be found via links on the first page “About this survey”. The English-language survey is open until January 31st.
Every answer is helpful!
