Well-established technology

The term is used in MDR Articles 52(5) and 61(8), which give such devices some flexibility in assessment and clinical evaluation. It is not limited to the devices listed in Article 61(6)(b), and similar devices with the same features may qualify.

• ‘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 well-established technologies are that they all have: o relatively simple, common and stable designs with little evolution; o their generic device group has well-known safety and has not been associated with safety issues in the past; o 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; o a long history on the market. Therefore, any devices that meet all these criteria may be considered “well-established technologies”.

MDCG 2020-6, Section 1.2, Additional terms not defined in MDR Article 2