The Commission Launches a Public Consultation and a Call for Input for the Assessment of the Regulatory Environment
The European Commission has launched a public consultation and a call for input on the regulation of Medical Devices and in vitro diagnostic Medical Devices in the European Union. The initiative is part of an evaluation process of the MDR Regulation (EU) 2017/745 and the IVDR Regulation (EU) 2017/746, giving all stakeholders the opportunity to express their feedback and input on effectiveness, highlighting issues and suggesting improvements.
The regulations, designed to ensure that only safe and effective devices reach the market, also aim to preserve the competitiveness and innovation of the sector. For this reason, the evaluation will focus on various aspects, including the effectiveness of regulations, economic impact and administrative burdens, with a special focus on small and medium-sized enterprises (SMEs). In addition, the analysis will address key issues such as the availability of devices, including the difficulties associated with ‘orphan devices’ and encouraging the development of innovative devices.
In addition, the consultation is an opportunity to examine the benefits of regulations for patients and end users.
Interested parties can submit their contributions until March 21, 2025.
The initiative could be linked to the resolution passed by the European Parliament on October 23, 2024, which emphasised the need to solve the most urgent challenges by the first quarter of 2025. The resolution drew attention to bottlenecks in device certification, highlighting how the resulting delays could jeopardise the continued availability of essential devices on the European market. In addition, the need to create a more flexible and rapid regulatory pathway was emphasised to facilitate the approval of orphan, paediatric and technologically advanced devices, thus responding to unmet medical needs. Improving transparency among notified bodies was another aspect addressed, to simplify certification procedures and make market access more predictable for manufacturers.
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01/22/2025
