2023 saw a number of important updates and amendments to the EU’s Medical Device Regulation (MDR). Medical device companies will continue to feel the impact of these changes into 2024 and beyond.

Artificial Intelligence (AI) is impacting every industry right now, and healthcare is no exception. Although it’s currently under-regulated, new regulations – like the EU’s AI Act – are on the horizon. That means medtech companies must strike the right balance between innovation and regulation. 
In the next couple of years, medtech companies using AI, and operating in the EU market, will need to adopt an entirely new regulatory framework. At the moment, their main point of reference is the Medical Device Regulation (MDR).

Determining whether a product is a medical device is a complex and time-consuming task. In fact, Article 2 of the EU’s Medical Device Regulation (MDR) defines a medical device with six different medical purposes – and over 70 related terms.