The EC has initiated a public consultation to assess the effectiveness, efficiency, relevance, and coherence of the EU regulations on medical devices (Regulation 2017/745) and in vitro diagnostic devices (Regulation 2017/746). This is a key opportunity for stakeholders to help shape the future of medical device regulations in Europe, ensuring that they continue to prioritize patient safety while supporting innovation.
Why Participate?
The European Commission is evaluating the implementation of these regulations since their adoption in 2017, examining how well they address current and future needs. The consultation seeks to gather evidence and data from various stakeholders, including economic operators, regulatory authorities, healthcare professionals, patient and consumer organizations, and academic experts.
The aim is to evaluate whether the regulations are:
Who Can Participate?
This consultation is open to a broad range of stakeholders, including:
Key Information:
The consultation will run from December 12, 2024, to March 21, 2025, and will offer various ways to contribute, including:
If you are involved in the medical device sector, this is your chance to share your insights and influence the future of EU regulations.
Get Involved Today! To learn more and access the full consultation document, download here the full document.
