While placing your medical device on the European Union (EU) market, obtaining CE marking is a mandatory step. This is essential to assure the end user that the devices available in the market are both safe and effective for use. A critical component for providing this assurance involves a thorough examination of the technical documentation for the medical devices.
The specifics for medical devices refer to a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process, or system. This includes the type of medical conditions the device is designed to diagnose, treat, monitor, alleviate, or prevent.
The European medical devices market, being the second largest in the world, is majorly driven by a growing patient population, technological advancements, and increasing healthcare expenditure. However, when it comes to expanding the medical device business into the European geography, a complex web of regulations and recent geopolitical changes adds an extra layer of challenge.
The European Union Medical Device Regulation (EU MDR) 2017/745 is a regulation that sets out the requirements for medical devices in the EU. The regulation provides the evaluation of medical devices prior to marketing, and one of the key requirements is the need for clinical investigations. Clinical investigations are necessary to assess a device’s safety and performance and demonstrate that it meets the requirements of the EU MDR. Under the EU MDR, the clinical investigation has been divided into three (03) components –
