February 25, 2025
Regulatory

EU Rules on Medical Devices and in Vitro Diagnostics – Targeted Evaluation

The EU Commission is currently conducting a participation process for the targeted assessment of the 2017 regulations for medical devices and in-vitro diagnostics. The Regulation (EU) 2017/745 on medical devices and the Regulation (EU) 2017/746 on in vitro diagnostic devices (IVD) were issued in 2017. The aim of this review is to assess the effectiveness, efficiency and proportionality of the existing regulations. Future needs, coherence with other EU measures and added value for the EU should also be taken into account.

 

The consultation has already started and closes on March 21, 2025. It is aimed at economic operators and their associations, healthcare professionals, patients and consumers, as well as regulatory experts.

 

The aim is to collect feedback from stakeholders, companies, scientists and other industry players.

 

The procedure offers the opportunity to critically examine the existing regulations and make suggestions for improvements. In particular, it examines how effective and efficient the current regulations are, whether they achieve their goals and what challenges exist in connection with their implementation.

 

Anyone interested can submit their opinions and comments directly on the EU Commission platform. Full details of the participation process and access to the comment platform can be found here [external link].

 

Source: European Commission