MedTech Europe has released findings from its latest survey, indicating that while access to notified bodies has improved for medical device manufacturers, significant challenges remain under EU regulations. The survey reveals ongoing uncertainty around costs, timelines, and predictability, with IVD manufacturers facing a 70% increase in maintenance and re-certification costs over a five-year cycle. Medical device manufacturers are experiencing a 50% increase. The survey also highlights that over half of conformity assessment time is spent outside the review phase, suggesting potential for streamlining. Concurrently, the MHRA has published guidance on new postmarket surveillance requirements for medical devices, set to come into force on 16 June, emphasising the need for manufacturers to implement comprehensive PMS plans and systems.