The EU Commission says this will save €2.1 billion — is that credible?

No, according to the paper “the general conformity assessment measures are estimated to provide around €2.1 billion in savings per year”. This is a grossly inaccurate statement. Industry figures place NB costs at less than 10% of overall MDR/IVDR compliance costs, further emphasising the proposal’s disproportionate focus on NB fees and not addressing the real cost drivers for manufacturers.
The total combined revenue of all 50 Notified Bodies across the EU was approximately €475 million in 2024. It is not possible to save more than four times an industry’s total earnings from that same industry — the math simply doesn’t work. This suggests the Commission’s estimates are based on flawed assumptions about how the system actually operates, and that the calculation takes into account safety missions that manufacturers would have to carry out, regardless of whether they make use of Notified Bodies or internal control systems. We therefore strongly warn about misleading figures that bear no reality to the actual market or current market practices.