Team-NB Position Paper on MDR/IVDR revisions
Team-NB, the European Association of Medical devices Notified Bodies, has published its Position Paper on the European Commission’s proposed revisions to the MDR and the IVDR. While the Association acknowledges that the proposed revisions provide opportunities to improve predictability, transparency and efficiency in conformity assessment, it has expressed concern regarding some aspects of the proposed revisions. These include what Team-NB perceives as reductions in
Call for feedback concerning revisions to the MDR and the IVDR proposed by the European Commission
The European Commission has launched a call for feedback concerning the proposed Regulation intended to simplify and reduce the burden imposed by existing rules governing medical devices and in vitro diagnostic medical devices in the EU that was published in mid-December 2025.
New draft Guidance on Trend Reporting
The Medical Device Coordination Group (MDCG) has endorsed a new draft Q&A document on trend reporting under the EU Medical Device Regulation (MDR) and the in vitro diagnostics Regulations (IVDR) (Trend Reporting Q&A (MDCG 2025-X)).
Article 88 of the MDR and Article 83 of the IVDR provide a framework through which manufacturers should report statistically significant increases in the frequency or severity