The Commission has launched a public consultation and a call for contributions on the Medical Devices (MD) and Medical Devices for In Vitro Diagnostic Use (MDI) Regulations, with the aim, in particular, of assessing the effectiveness of the rules, the costs and administrative burden they entail—especially for SMEs—as well as the benefits for patients and users. The assessment will also examine the impact of the rules on the availability of devices, including “orphan devices,” and on the development of innovative devices.
The consultation and call for contributions will be open from December 12 to March 21, 2025.