As medtech companies work to comply with the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), stakeholders disagree on whether legislative action is needed to revise the regulations to prevent products from leaving the EU market.
A 16 October panel at the 2024 Medtech Conference included experts who discussed the progress made in transitioning to MDR and IVDR from the previous directives. They agreed that the medtech industry is struggling to comply with the new regulations, and some advocated for new legislation to prevent products from leaving the EU market. Such concerns have already led EU authorities to extend the transition periods for both regulations.
The panel took place a day after Medtech Europe sent a letter to Stella Kyriakides, European health and food safety commissioner, asking her to take several steps, including implementing legislative reforms for MDR and IVDR. The industry group also asked for bridging measures to prevent products from leaving the EU market until such reforms are enacted…
