TEAM-NB Paper Offers Guidance For Manufacturers On IVDR Technical Files

What do notified bodies designated under the EU In Vitro Diagnostics Regulation expect to see in manufacturers’ technical documentation during conformity assessments? A new TEAM-NB position paper helps companies through this process.

Multi channel pipette loading biological samples in microplate for test in the laboratory. — • Source: Shutterstock

The EU notified body industry association, TEAM-NB, has published a position paper based on best practice guidance documents from notified bodies designated under the In Vitro Diagnostics Regulation that aims to unify what they require in technical documentation submitted by manufacturers.

The 35-page document sets out the information that should be supplied by IVD manufacturers, in line with Annex...