Dear Members, MedTech Europe have published the reflection paper on Notified Body Sampling of technical files under the IVDR. This is part of the work that MedTech Europe is under taking to look at reducing administrative burden as part of the review of the implementation of the IVDR. You can find the published document on MedTech Europe website here: https://www.medtecheurope.org/news-and-events/news/sampling-under-in-vitro-diagnostics-regulation-medtech-europe-proposal-for-a-more-risk-based-approach/…
Ben KempAugust 4, 2025