Relieving the regulatory burdenCentral to his critique is the disproportionate clinical data burden placed on well-established and low-risk products. Yet under the MDR, manufacturers of long-established devices find themselves repeating the same clinical data exercises as their competitors, for products whose safety record is not in question. The case for treating such products differently is, in his view, already being made by the market itself. Since 2021 – now more than five years ago – legacy devices have remained on the market without significant changes to their design and intended purpose. ‘If those devices were not safe,’ Möller says, ‘it probably would have been noted by now.’