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EU IVDR: Understanding the New QMS Requirements

On 26 May 2017, the European Commission (EC) introduced the In Vitro Diagnostic Regulation (IVDR 2017/746), which replaces the current In Vitro Diagnostic Directive (IVDD 98/79/EC) and introduces major changes for IVD manufacturers throughout the European Union (EU). The IVDR: The Fantastic 4 (Systems) or 1 System for All? The IVDR clearly lays out that … Continued