Commission launches public stakeholder consultation on MDR and IVDR review

On 23 October 2024, the European Parliament issued a resolution highlighting the urgent need to review Regulation 2017/745 MDR and 2017/746 on medical devices and in vitro diagnostics, to address the risk of shortages of medical devices in Europe as a result of the difficulties, delays and high costs of certifications that have weighed on companies producing medical devices and medical diagnostic devices and which have led, on the one hand, to a substantial slowdown in development and innovation and, on the other hand, in many cases, to the interruption of the supply of some medical devices on the territory of the Union.

The urgency of the review was particularly underlined by the short time frame in which it was requested, within the first quarter of 2025.

Following the resolution, the Commission launched a public consultation and a call for feedback on EU 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 the call for feedback from stakeholders will be open until 21 March 2025 and can be accessed here.