Well established technologies (WET) are relatively simple devices, having common and stable designs with little evolution, well-known safety and clinical performance characteristics and a long history on the market. Criteria for identifying WET have been set in Medical
Device Coordination Group guidance (MDCG 2020-6).
Article 52(4) of Regulation (EU) 2017/745 lists a number of technologies which, by virtue of being WET, may benefit from a simplified approach, in this case the exemption from the requirement of the assessment of technical documentation for each device, in the course of the conformity assessment procedure. Furthermore, Article 52(5) empowers the Commission to expand the list of WET to devices similar to those listed.
Based on the experience gained so far with the MDR, this delegated act aims at expanding the lists of type of class IIb implantable devices in Article 52(4) of Regulation (EU) 2017/745 to exempt them from the requirement for the obligation to perform an assessment of the technical documentation for every device.