Placing a medical device in the European Union and the United States can be challenging and daunting at the same time which come with added stringent regulatory requirements. The European Union and the United States both operate under a very intricate and complex regulatory framework to oversee the medical devices. Both European Union Medical device (EU MDR) and United States Food and Drug Regulation Authority (US FDA) have a very stringent regulations and are designed to guarantee safety and efficacy for the medical devices.
It’s worth noting that the FDA and the EU MDR have set stringent quality standards and quality systems for the medical devices to conform to the ISO standards, which emphasize the critical importance of designing, safety and the quality of the medical devices.
Let’s dive into a comprehensive video which focuses on the key difference between the EU MDR and the US FDA rules and regulations for placing a medical device in the US and EU.