Through collaborations with industry and international regulatory platforms (International Medical Device Regulators Forum and Global Harmonisation Working Party ), MedTech Europe works to streamline regulatory processes, reduce barriers, and foster access to innovation and life-changing medical technologies worldwide.
At the same time, MedTech Europe monitors and addresses the impact of the transition to EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) on product registrations in third countries. This is done by means of a continuous impact assessment and mapping of the country requirements in response to the implementation of EU MDR/IVDR, awarenesses-raising on the regulatory changes brought by the EU Regulations and their amendments (e.g., webinars) and the publication of resources dedicated to non-EU/non-EEA stakeholders.
