Council and European Parliament reached political agreement on the medical devices and in vitro diagnostic medical devices regulations

Posted on 02.06.2016




Following the May 25th trilogue meeting, MedTech Europe, the alliance of Eucomed and EDMA, are pleased to hear that a political agreement has been reached on the new 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 recognises 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 yesterday’s agreement is a significant step towards finalising modern medical devices and in vitro diagnostic legislations that recognises the specific nature of medical technologies, contributes to increased patient safety and fosters the development of innovative healthcare solutions.

Entering the implementation phase, it is critical that the large volume of secondary legislation transfers this complex framework into feasible and implementable rules, whilst avoiding unnecessary bureaucracy for all involved parties. The industry will continue to work together with legislators and other stakeholders to achieve this objective.

At the same time, EDMA and Eucomed will actively support their members by providing the expertise and guidance to transition effectively and smoothly to the new regulations.