Tecan has become one of the first companies to meet the requirements of the European Union’s In Vitro Diagnostic Regulation (IVDR) 2017/746 (Annex IX, Chapter I and III), successfully completing certification of its IBL International DHEA Saliva ELISA diagnostic assay kit through BSI Notified Body 2797. 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 to avoid the risk of being forced out of EU markets.
Addressing the challenges of certification
Tecan is recognized as a global leader in quality and regulatory affairs (QARA), and is leading the sector in the management of the IVDD to IVDR transition. The company’s unique position as both an IVD and OEM manufacturer, combined with many years of expertise in IVD product registration globally, means that Tecan is ideally placed to address the challenges of certification for both its own products and those of its partners.
Guenter Weisshaar, Senior Vice President for QARA at Tecan, commented: “IVDR is a major business challenge for IVD manufacturers, requiring a significant investment of time and resources to ensure regulatory readiness. We are very pleased to be one of the first manufacturers to achieve product certification under the new regulations, and will be using our knowledge of this process to support and accelerate the certification of our IVD assays and devices, together with those of our OEM partners.”
Erica Conway, Global Head of IVD Medical Devices at BSI Notified Body 2797, added: “IVDR is a significant challenge to the in vitro diagnostic devices industry. It places greater regulatory requirements on everyone in the system, from manufacturers and notified bodies to importers and distributors. We are proud to continue to support our clients in the certification of devices under IVDR, ensuring that products remain available as we approach the May 2022 deadline.”