Council & Parliament adopted amendment to the MDR / IVDR

On 7 March, the Council of the EU has officially adopted the amendment to the MDR and IVDR. This follows the positive vote from the European Parliament last month and paves the way for the formal signature of the legislative text, which is scheduled for 15 March. Shortly after, it will be published in the Official Journal and enter into force on the day of its publication. The Commission will work together with Member States and all stakeholders to provide the necessary support to implement this legislative amendment.

Looking ahead

The Medical Devices Regulation and the In Vitro Diagnostics Regulation have both been amended at least once to delay the start of the new rules for several years. The aim of the new rules is to ensure that all devices used across the bloc meet higher quality and safety standards through a more rigorous clinical evidence assessment by notified bodies, following public scandals on issues such as substandard breast implants. But the rules have placed extra burdens on some companies, especially small firms making products used rarely and in children. 

On 14 March, POLITICO reported that EU Health Commissioner Stella Kyriakides stated “We have a long road ahead before the transition to the new rules is completed and patient safety is increased.” She concluded that “by 2027 at the latest, we will undertake a broader evaluation of the regulatory framework. That will of course be the moment to decide together if changes to our framework are required.”

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For further information regarding the MDR/IVDR or how to join our Regulatory Working Group, please contact Leander Vranken (vranken@eucope.org)