S&Ds: Medical device safety is non-negotiable and a review must be based on a proper impact assessment

Today, the S&D Group voted in favour of a resolution on the medical devices regulation in the European Parliament, securing an outcome that recognises the difficulties within the legal framework. The resolution urges the Commission to address the immediate issues using the tools at hand and advocates for a revision only after a thorough impact assessment.

In this resolution, the S&D Group fought off calls from the European People's Party (EPP) to abolish recertification of devices without proper assessment, and urges to amend the legal framework only with a thorough evaluation. Today's vote represents a clear commitment by the S&Ds to ensure patients' safety above all, and work constructively to address the issues in the current legal framework to find long-lasting solutions.

Tiemo Wölken, S&D coordinator for the environment, public health, and food safety committee, said:

"For the S&D Group the message is clear: first and foremost we need to ensure patients' safety in the long term. At the same time, we need to address the problems in the current framework to ensure devices stay available to EU citizens. In a potential revision, we must act responsibly. Calls by the EPP to amend the regulation without an impact assessment and abolish recertification without assessing the consequences risks putting patients in real danger and runs contrary to expert opinions. This is not acceptable for our group, nor fair to patients.

"We call now on the Commission to use the powers at its disposal to address the most immediate challenges to ensure that devices stay on the EU market in conformity with the highest safety standards. While certain aspects of the regulation may require revision, we must not rush this process and ensure a long-term solution is found.''

Note to editors:

The Medical Devices Regulation, adopted in 2017, was introduced to modernise safety and performance standards for medical devices in response to past scandals involving devices that compromised patients' safety, such as faulty implants. By requiring certification, the updated regulation guarantees that patients across the EU have access to high-quality, safe medical devices. Although its implementation has encountered challenges, the S&D Group acknowledges the importance of these reforms to prioritise patients' safety, and has actively worked to resolve issues to ensure the full enforcement of the new rules.