For medical device manufacturers, getting started with the EU’s Medical Device Regulation (MDR) is a huge challenge. With over 120 articles, close to 20 annexes, and more than 200 pages – plus all the accompanying guidance documents – it’s an enormous regulation to decode.
Not only is it vast, the MDR also continuously evolves alongside the state of the art, new standards, and related regulations (such as the AI Act). Even for experienced compliance professionals, it can be a challenge to correctly decipher the MDR.
To help you get started, here’s our outline of the best starting point for medical device manufacturers to dive into the MDR.
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).