The European Commission (EC) has announced an evaluation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
There is a call for evidence with a submission period running from 12 December 2024 until 21 March 2025.
Regulations 2017/745 and 2017/746 were established in 2017 to ensure that manufacturers, importers, distributors and other stakeholders were compliant with the necessary procedures to guarantee the safety and effectiveness of devices that are available to the public.
The evaluation aims to assess whether Regulations 2017/745 and 2017/746 continue to be safe, effective and have EU added value. It will also help the Commission to consider if there should be changes to the regulations based on current and future needs, in order to adjust to the continually evolving regulatory environment.
A focus will be on the availability of devices, especially orphan devices, and the impact of the regulations on SMEs and others. It aims to consider the effect of these regulations in EU Member States and across the European Economic Area.
Stakeholders have the opportunity to express views and share evidence to help determine the overall effectiveness and safety of these regulations. Before submitting, it is recommended that the requirements for appropriate feedback are first understood. The feedback will be published online, with planned adoption in the fourth quarter of 2025.
For further information, please refer to the European Commission’s website.
