Counts here are a floor, never a total: they cover the 326 consultation files tracked so far (29,503 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
Sufficient views were shared on the excessive burden of complying with the IVDR. Here are a few opportunities for improvement: 1. Clear communication about what is allowed, even though it is not specifically formulated in the IVDR. This includes: (a) the non-necessary fulfilment of certain requirements (e.g.
Filed in German · English published by the European Commission
The application of the MDR/IVDR Regulations to existing products, some of which have proved for decades that they do not pose a risk to patients, is incomprehensible. Unnecessary requirements which only serve to complete paper, but do not make the products themselves safer at all. These documents are then subject to exorbitant fees from notified bodies, which are justified by the expertise of their staff.
Filed in German · English published by the European Commission
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