On May 26, 2022, In Vitro Diagnostic Directive (IVDD) will be replaced by In Vitro Diagnostic Medical Device Regulation (IVDR), introducing a new approach to how in vitro diagnostic devices (IVDs) will be regulated in the European Union (EU). In Vitro Diagnostic Medical Device Regulation (IVDR) replaces the previous IVD directives to enable reliable and effective IVDs. The amended directives include regulatory changes and requirements to enhance the safety and efficacy of IVDs for non-EU manufacturers and economic operators with commercial operations in the European Economic Area (EEA).
Article 10 of IVDR mandates a quality management system to ensure that manufacturing, change control, customer complaints, resource management, supplier and subcontractor controls and validation, performance evaluation, quality test, UDI labeling, post-market surveillance, etc. are according to the approved QMS and Post-Market Surveillance (PMS) plans. Implementing a pre-validated Enterprise Quality Management System (EQMS) will undoubtedly make life easier for quality leaders who are gearing up to meet the stringent and complex requirements of IVDR.
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