IVD

With the updated in vitro diagnostic medical devices (IVD) classification moving at least 80% of IVDs under Notified Body scrutiny (compared to 20% previously!), most manufacturers should now be gearing up to shift from self-certification to notified body oversight as we enter into the third year of the In Vitro Diagnostic Regulation's transition period. A crucial issue manufacturers need to assess is whether they have the necessary clinical evidence to comply with the regulation. Due to a lack of previous experience with notified bodies, and a perception that there is still a lot of time before the transition period ends in 2022, some manufacturers are underestimating how much evidence is now required to support the safety and performance of their device(s). The new IVD classification system is based on defined risk-based categories, where 'A' is low risk and 'D' is high risk; higher risk entails greater requirements for clinical evidence as well as greater oversight from a notified body. The challenge for legacy products is that grandfathering is not an option, meaning that each device must be re-assessed according to the level of risk. According to the IVDR, clinical evidence must support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan. Performance evaluation reports should demonstrate the following elements: scientific validity; analytical performance; and clinical performance. Scientific validity: • How much research has been conducted in relation to the device and its intended purpose? • How robust are the results of proof of concept studies? • What technology is the device based on? Analytical Performance: • Which tests have been carried out? • Which standards were used for these tests? • Are these standards harmonized? • How much-recorded evidence exists? Clinical Performance: •...