Whitepaper: The in-vitro diagnostics Regulation (IVDR): Unravelling the challenges of the transition

Evnia news


This whitepaper discusses the new European In-vitro Diagnostic Medical Devices Regulation, EU-IVDR 2017/746 and the increased requirements it introduces to the IVD Industry. The IVDR-specific provisions with respect to classification, General Safety and Performance Requirements (GSPRs), Technical Documentation, Economic Operators (EOs), Conformity Assessment and clinical data/performance evaluations are presented and discussed.

We outline:
– The IVD Regulation and its main differences from the IVD Directive;
– The new, risk-based classification system and how it changes interventions of Notified Bodies;
– The changes in Conformity Assessment;
– The increased requirements for clinical evidence and the respective changes in performance evaluations;
– The changes introduced in the Quality Management system (QMS), and therefore to Post-Market Surveillance (PMS) and Risk Management (RM) activities, which must now cover the entire lifetime of IVDs.

The new IVD Regulation has introduced various new or updated requirements in an effort to ensure the continued safety of end-users and patients. However, by doing so, it requires from all stakeholders of the IVD Industry, both regulatory and economic operators, to implement effective transition strategies.

The shortage of Notified Bodies is alarming for the IVD Industry but it should not halt the remediation activities of manufacturers. The new conformity assessments, the risk-based up-classification of a huge number of IVDs as well as the lifetime-long PMS activities are expected to add a considerable workload to the Industry.

The new and stringent requirements on clinical evidence is putting extra pressure on all stakeholders but should be treated as a motivational factor that will trigger remediation activities in order to ensure timely compliance with the new safety and performance evaluation requirements.

More important than everything, manufacturers should not delay their preparation, as effective from 27 May 2022, they may not be able to market their portfolio in the European Union without conformity with IVDR requirements.