Companies entering a medtech market for the first time – or even those transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) – face a mountain of regulatory compliance. Whether you’re two people in a room, or tens of people on an office floor, resources can quickly become thin. The fact is, people in smaller organizations often have to fulfill multiple roles. 

Now add the burden of regulatory compliance into that mix. Who in your organization has the time, expertise, and strategic know-how to get it done? There’s no quick fix, but wouldn’t it be great to lean on a regulatory expert? A trusted partner who’s walked the same road before, and even has its own medtech products on the market. That’s the advantage of regulatory consultancy from Peercode. 

Medical devices have a direct impact on people’s health and the quality of care they receive from healthcare providers. For that reason, the medtech industry is tightly wrapped in regulation, and a product’s quality and correct usage are paramount. 

Legislation like the EU’s Medical Device Regulation (MDR) is there to enforce consistent and stringent standards for all. But, for medtech companies bringing products to multiple markets, it adds to a labyrinth of legislation. Here are our expert tips for navigating it.

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.