04 November

HEALTHCARE

MDR and IVDR: A Necessary Review for the Future of Medical Devices

04/11/2024

On October 23, 2024, during a plenary session, the European Parliament voted on Resolution 2024/2849(RSP) regarding the urgency of revising the Regulations on medical devices and in vitro diagnostic devices. The resolution emphasizes the need to simplify regulatory processes and reduce administrative burdens on companies, with the aim of accelerating the market entry of medical devices. The text highlights the importance of ensuring quicker access to medical devices for patients with rare and pediatric diseases, facilitating the collection and exchange of clinical data from national registries. The resolution underscores the urgent need to significantly accelerate the assessment timelines by notified bodies to ensure timely access for patients to innovative and life-saving medical devices. The European Commission has welcomed these requests and announced the launch of a targeted evaluation of the MDR/IVDR starting on November 15. MedTech Europe has welcomed the European Parliament's invitation to the Commission and has confirmed its commitment to work closely with the European Commission, the European Parliament, and Member States to ensure that the MDR and IVDR regulations achieve their innovation goals for public health in Europe.