Summary of IVDR Scope and Key Dates The European Union In Vitro Diagnostics Regulation 2017/746 (EU IVDR) expanded upon IVD Directive 98/79/EC (IVD-D) requirements, which have been in effect since 1998. The changes come into effect immediately, without having to be implemented into the respective states’ laws. Whilst some things, like the number of risk device classes, are remaining the same, the scope of the IVDR changes are wide reaching, with key changes as follows: Product scope expansion Reclassification of devices according to risk More stringent clinical evidence More stringent documentation Implementation of unique device identification Rigorous post-market surveillance Nomination of a responsible person for regulatory compliance Increased Notified Body involvement The intention of the regulation is to set tighter and broader requirements for the quality, performance and safety of IVD products, with implications for both manufacturers and consumers. Learn more about Yourgene's IVDR timeline on our website: https://hubs.la/Q0281mW10 Yourgene are committed to sharing our IVDR expertise with our distribution partners and end users – we will be bringing you informative content to help guide you through your IVDR fears. If you have any questions about IVDR, please contact dpyd@yourgenehealth.com to speak with an expert. #DPYD #IVDR #DPYDGenotyping #PrecisionMedicine #Pharmacogenomics #DPD
