Following the May 25th European trilogue meeting, a political agreement has been reached on medical devices and in vitro diagnostic medical devices regulations.
The two regulations on medical devices and in vitro diagnostics include measures which will have a significant impact on patients, regulators and industry. Serge Bernasconi, CEO of MedTech Europe says “As said before, the medical industry recognizes the importance of these updated regulations. The implementation will require substantial resources from all stakeholders, including industry. It is thus essential to keep the overarching goals of patient safety and innovation in mind during the translation into implementable rules.”
It has been a long process, and the agreement is a significant step towards finalizing modern medical devices and in vitro diagnostic legislation that recognizes the specific nature of medical technologies, contributes to increased patient safety and fosters the development of innovative healthcare solutions.