Team NB fully supports the objective of improving predictability, consistency and transparency in conformity assessment. However, several concerns remain, especially the risk that the proposed reductions in controls could have potential consequences for patient safety, trust, and market surveillance. In addition, the assumptions made by the Commission to estimate the savings appear unrealistic in light of NB revenues.
Team-NB-PositionPaper-MDR-IVDR-revision-impact-on-the-sector-20260302