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 61(6)(b) 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 to perform clinical investigations.
Furthermore, Article 61(8) 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 devices in Article 61(6)(b) of Regulation (EU) 2017/745 to exempt them from the requirement to perform clinical investigations.
source: https://lnkd.in/dF9RFfsC