The European Commission has initiated a public consultation and call for evidence as part of a targeted evaluation of the EU legislation on medical devices and in vitro diagnostic medical devices. This consultation offers stakeholders the chance to share their views on the effectiveness of the current regulations and identify any potential shortcomings.
The regulations governing medical devices and in vitro diagnostics aim to ensure that only safe and effective products are available on the market, while fostering a competitive and innovative industry.
The evaluation will assess various factors, including the effectiveness of the rules, the costs and administrative burden, particularly for SMEs, and the benefits to patients and users. It will also examine the impact of the regulations on device availability, including for “orphan devices,” and their effect on the development of innovative technologies.
The consultation and call for evidence will remain open until March 21, 2025, and can be accessed using the following link
