ARTICLE SUMMARY:
After a seismic shift in a regulatory regimen like the MDR, one might expect a pause in further changes to allow industry and regulators to get used to the new rules. But prospective changes in significant areas like diagnostics, artificial intelligence, and health technology assessment could be right around the corner. Senior MedTech Europe leaders Serge Bernasconi and Oliver Bisazza share with us the likelihood that these future transformations could occur.
With the long-awaited Medical Device Regulation (MDR) now reality, it is understandable that both industry and regulators would benefit from an interregnum in further regulations in order to first understand both the meaning and implementation process for the new rules. However, when looking at a variety of regulatory proposals that appear to be on the horizon, nothing could be further from the truth. In this article, we explore with Serge Bernasconi and Oliver Bisazza, CEO and director general, respectively, of MedTech Europe, the device trade association, a series of legislative and regulatory proposals that appear to be on track that potentially could significantly impact the device industry.