Despite cautious hope, the mood in the room was rather tense. The certification backlog is paralysing the industry and many SMEs are groaning under the burden of increasing reporting obligations. Company representatives called for clear rules, more predictability and less paperwork. SMEs in particular feel left alone in the jungle of regulations, while clinical trials are increasingly being outsourced to the USA.
Whether it's AI regulation, chemicals law or data access, the interfaces between the different areas of law are numerous and complicated. The desire for relief is loud and the expectations of politicians are clear. The industry is waiting for action instead of new promises. Because if you want modern medical technology from Europe in the future, you have to pave the way for it now.
News from "BVMed"
