The new Regulation brings with it significant changes to the regulatory requirements for IVD medical device manufacturers and introduces a new rule-based classification system with increased Notified Body involvement. The new rule-based system supersedes the current list-based approach in the Directive. This change means that, as classification rules will be applied to all IVD medical devices, up to 90% of IVD medical devices will require a notified body for conformity assessment.
In addition to the change in classification rules, there is also increased harmony between the IVDR and the Medical Device Regulation (MDR), the equivalent for medical devices, including a focus on clinical evaluation transparency through the wider supply chain.