Patient safety is paramount for medical device companies. It’s the cornerstone of both the design and regulatory approval process under the EU Medical Device Regulation (MDR). One of the most critical and complex areas where safety must be proven is biocompatibility. Whether you’re developing skin-contacting sensors or implantable devices, demonstrating that your product is safe for the human body is critical for gaining and maintaining market approval in Europe.

Under the EU’s Medical Device Regulation (MDR), the rules around sterilization impact almost every aspect of product design, manufacturing, packaging, and documentation. For medical device manufacturers placing sterile products on the EU market, sterility isn’t just another technical specification – it’s an added weight on their regulatory burden. Here’s what you need to know about sterility standards and MDR compliance.

Bringing a new medical device to the EU market – or to any market that’s adopted the EU’s Medical Device Regulation (MDR) – is a complex process. Whether you're a medtech startup or an established company, adding a new medical device to your product line-up and navigating MDR compliance is a necessity. 

Miss a key step in the compliance process, and you could face costly delays and an increased chance of rejection by your Notified Body. To help you successfully launch your medical device, our experts have compiled this guide to the key steps for compliance.