Moderator: Hugh Harvey, Managing Director, Hardian Health
The years 2021 and 2022 have been intense in terms of regulation for the MedTech sector in Europe, including the implementation of the MDR and IVDR, the advancement of Health Technology Assessment and the proposed EU AI Act. How can MedTech innovators navigate this complex regulatory framework and integrate it in their strategic development? What is the impact on the business model and the cost of the innovation process for small players at early stage? How can regulation be leveraged to be more used as a guide and not only as a constraint?