Simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and support of the European Medicines Agency for the expert panels on medical devices and the list of Union harmonisation legislation

This legislative proposal (COD) aims to simplify and reduce the burden of EU rules on medical devices and in vitro diagnostic medical devices, with support from the European Medicines Agency for expert panels. The amendments focus on broadening the definition of clinical data to include studies published in scientific literature, streamlining how authorities decide a product's regulatory status via EMA-supported expert panels, and aligning the medical device regulations with the EU's artificial intelligence rules to avoid overlapping requirements. Other amendments address criteria for breakthrough and orphan devices, removing the maximum validity period of notified-body certificates, emergency authorisations during public health emergencies, clarifying cybersecurity incident reporting, deadlines for expert panel opinions, conditions under which health institutions may manufacture devices in-house for specific patient groups, and human oversight requirements when health institutions use AI-based medical devices.