The new in vitro diagnostic regulations (IVDR) that have been published in the official journal of the European community (OJEC) on 5th May 2017 will replace the existing in-vitro diagnostic medical device directive (IVDD) and would be enforced from 26th May 2022. IVDR brings in substantial changes in place of directives that had directed the landscape earlier. Whilst the existing regulatory approach remains the same with respect to supervision of notified bodies, conformity assessment procedure, performance evaluation, performance studies, vigilance and market surveillance. These are significantly reinforced in the present regulation.
Though the transition period is five years, medical device companies should start the transitional activities since the risk-based classification defined in IVDR brings nearly 80% of devices in market under classification that needs notified body involvement. IVDR compliance is not one-time remediation activity that can be achieved immediately, as it involves changes in quality management system (QMS), classification of devices, technical documentation, product risk management, performance evaluation, clinical evidence, labeling, supplier management and post-market surveillance.