News & Insights Search

This article highlights the similarities and differences in the acceptance of real-world evidence (RWE) as clinical data for medical devices in the US and the EU. It will explore the industry perspective on the use of RWE in the US and the notified body perspective on accepting RWE as clinical evidence. The article includes four anonymized case studies in which RWE collected by postmarket clinical follow-up (PMCF) activities was accepted by a notified body in support of CE marking.

The journey of a medical device start-up from concept to market is fraught with challenges, particularly when meeting stringent regulatory requirements for clinical data. This article provides a comparative analysis of these requirements between the EU and US, with a particular focus on the unique hurdles faced by start-ups and spin-offs and the resources available to them.

This article examines clinical evaluation under the EU MDR from the perspective of clinical experts from three notified bodies. They anticipate new guidance on clinical evaluation, with an update of MEDDEV 2.7/1, rev. 4, and a definition of orphan devices and clarification on their use in the EU. The article provides useful information for manufacturers and highlights published expert scientific opinions aimed at notified bodies. It also discusses the expanding use of real-world data and evidence (RWD and RWE) for confirming the safety and performance of medical devices, especially in postmarket clinical follow-up (PMCF).