Regulatory clearance: How are outcome measurements critical?

Abstract

In May 2017 the European Medical Device Regulation (MDR) was published to replace the current Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). After a transition period of 3 years (ending May 2020) the MDR will apply in the European Union (EU). With this new legislative framework, the requirements for placing new medical devices and keeping existing medical devices on the EU market will become more stringent. This is mainly due to the focus on clinical data for all medical devices regardless of their classification and the increased requirements on the post market surveillance system. In most cases, the MDR will require pre-market clinical studies for implantable medical devices and devices falling in the highest risk class (Class III). Since 2000 there has been a significant increase in the quantity and quality of publications in the fields of orthopaedic and orthopaedic trauma surgery. However, there is still a large number of medical devices without direct clinical data which rely on market experience and the established level of a specific technology or a group of devices. Due to this fact, and the fact that the new MDR is requiring sufficient clinical data for devices which shall stay on the market after May 2020, there is an increasing need for new clinical data sources reflecting the real-world use of medical devices.