Key challenges During IVDR Transition

1. Key challenges During IVDR Transition The new in vitro diagnostic regulations (IVDR) that have been published in the ofcial journal of the European community will replace the existing in-vitro diagnostic medical device directive (IVDD) and would be imposed from 26th May 2022. IVDR brings in substantial changes in place of directives that had directed the landscape earlier. The key challenges that exist for the transition are: Classification: The re-classification of devices that will bring more than 70% of the devices in the market under notified body assessment for the first time. Re-assessment of devices as per Annex I, II and III and compilation of technical documentation as per Annex II and III for all product lines becomes imperative and remediation needs substantial time and efort. Clinical Evidence: Increase in clinical testing requirements for new and legacy devices. Also due to re-classification, the devices that do not require this data previously have come under the purview of this requirement now. Supplier Management: subcontractors / entire supply chain becomes critical and the existing contractual agreement with all stakeholders has to be revisited to ensure the new requirements are met. Control over the suppliers / UDI and EUDAMED : UDI and new data elements that have been introduced require the manufacturers to not only deal with their product labels and IFU but also to have control over the labels of their importer (Article 13). www.makrocare.com