Italy: Revision of EU regulations on medical devices and in vitro diagnostic medical devices

10 Dec 2024    1 minute read
Sectors Healthcare & Life Sciences

In brief

With Resolution No. 2024/2849 of 23 October 2024, the European Parliament called on the Commission to propose, by the end of Q1 2025, delegated and implementing acts to Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices.

Contents

Key takeaways

Specifically, to address the challenges encountered in implementing the aforementioned Regulations, which, in addition to preventing the certification and approval of medical devices and in vitro diagnostic medical devices, have resulted in shortages of same devices, thus restricting patient access to innovative and life-saving therapeutic and diagnostic technologies, the Resolution highlights the urgent need for action to streamline regulatory processes, improve transparency, and eliminate unnecessary administrative work for notified bodies and manufacturers.

The Resolution also calls on the European Commission to introduce fast-track and priority procedures for the approval of innovative technologies in areas where medical needs are not being met and for devices related to health emergencies, and stresses the need to establish a clear definition of an "orphan device" that can facilitate the adoption of harmonized measures throughout the EU.

Finally, in order to ensure continuous monitoring of device availability in the EU market, the Resolution stresses the need for full and urgent implementation of European database on medical devices (EUDAMED), so as to increase transparency and provide better access to relevant information.

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