The Commission has launched a public consultation and a call for evidence on the EU’s legislation on medical devices and in vitro diagnostic medical devices, as part of the targeted evaluation of these rules.
The consultation provides stakeholders with the opportunity to express their views on how the current rules are performing and to highlight possible shortcomings.
The Regulations on medical devices and in vitro diagnostics aim to ensure that only safe and effective devices are available on the market, while supporting a competitive and innovative industry in this field.
The evaluation will look among others at how effective the rules are and at the costs and administrative burden of the rules, especially for SMEs, and at the benefits for patients and users. The evaluation will also consider the impact that the rules have on the availability of devices, including ‘orphan devices’ and on the development of innovative devices.
The consultation and call for evidence will be open until 21 March 2025 and are accessible here.
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