Delegated acts on well-established technologies published
The European Commission has published two delegated acts in the Official Journal of the European Union (OJEU) introducing additional well-established technologies (WET) under the Medical Devices Regulation (MDR). Well-established technologies are generally considered to be relatively simple medical devices with stable and widely accepted designs, well-documented safety and clinical performance, and a long history of ...
New Delegated Acts under the MDR Introduce Targeted Relief for Well-Established Technologies
Two new delegated acts under the EU Medical Device Regulation (MDR)—C (2026) 1798 and C (2026) 1809—have been adopted, introducing important updates for manufacturers of certain categories of medical devices. Both acts focus on well-established technologies (WET): devices that are widely recognised as safe and effective due to their simple, stable design, long-standing clinical use, ...
