’Well-established technology’: this terminology is used in Article 52(5) and Article 61(8) of the MDR, but is not defined in these articles. The term is not restricted to the devices listed in Article 61(6b); Article 61(8) explicitly states that this includes
devices similar to the exempted devices listed in Article 61(6b), which might be added to that list in future. The common features of the devices which are wellestablished technologies are that they all have:
- relatively simple, common and stable designs with little evolution;
- their generic device group has well-known safety and has not been associated with safety issues in the past;
- well-known clinical performance characteristics and their generic device group are standard of care devices where there is little evolution in indications and the state of the art;
- a long history on the market.
Therefore, any devices that meet all these criteria may be considered “Wellestablished technologies”.
[Definition according to MDCG 2020-6 No. 1.2]