David Egbosimba

David is a Solutions Delivery Manager at Maetrics with extensive experience as a medical writer, authoring numerous Clinical Evaluation Reports in a variety of medical device therapy areas. David is a clinical professional with a background in clinical affairs, clinical development and clinical research in both the Medical Devices and IVD industries.

At Maetrics, David has supported clients by providing comprehensive CER gap analysis and developing tailored CER strategies, for novel and legacy devices, to facilitate and confront the challenges of transitioning to the EU MDR. David is able to apply a high level of management acumen to drive clinical projects forward and to achieve project success.

Prior to joining Maetrics, David was a Clinical Affairs Manager for innovative IVD SME, Mologic Ltd, where he established a Clinical Affairs department utilizing his extensive clinical research experience and clinical development knowledge to provide support and strategic oversight through all phases of the product development life cycle.

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: •...