The valuable insights gained from this process will now be applied to the registration of Tecan’s complete portfolio of specialty IVD products – as well as to help its OEM partners ensure they are ‘IVDR ready’ – ahead of the May 2022 transition deadline.
The new IVDR is intended to increase the safety of all IVD products, including all innovations developed over the past decades. It represents a major regulatory overhaul, requiring reclassification and certification of all EU-registered IVD assays and devices. Introduced in 2017, it extends the scope of the outgoing IVDD to cover more devices and technologies – as well as supply chain and lifecycle management – and signifies a shift from a primarily ‘self-certification’ model to a requirement for notified body oversight. This greatly increases the regulatory burden for IVD manufacturers and notified bodies alike, making it essential to begin the certification process as soon as possible ...
