Before the introduction of the Medical Device Regulation (MDR), medical devices in the EU were certified under the Medical Device Directive (MDD). Many of these so-called ‘legacy devices’ still remain on the market under valid MDD certificates.

However, as the EU slowly shifts to the MDR, medical device companies must transition their products to the new regulations. The MDR is more stringent than its predecessor, so it’s easy to see it as an increased and unwelcome burden. 

That’s why we’re dedicated to making the transition easier, helping you turn mandatory regulatory transition into a valuable business opportunity. Read on to learn more.

Regulations around medical devices rarely stand still. A number of factors, most notably the EU’s landmark AI Act, mean 2025 is shaping up to be a milestone year in the field of regulatory compliance for medtech products. 

Medtech companies typically tackle the compliance challenge in two ways. First, by staying on track to meet upcoming regulatory deadlines. Second, by being ready to respond and adapt to regulatory changes as they happen. To help get your compliance efforts off to a flying start, here’s a list of what’s hot for 2025 and beyond.

Preparing an effective technical dossier for your medical device products is rarely straightforward. One of the major considerations is how you define your product. Is it one product, perhaps configurable, or is your product part of a family? In fact, this crucial step can be the difference between a manageable workload and an overwhelming pile of documents and separate dossiers.

For medical device manufacturers already established in the EU market, transitioning to the MDR is an additional compliance burden. This is especially true when you have a portfolio of products to re-certify under the latest regulations. That’s where careful planning, and a more strategic approach to structuring your products, can help ease the burden.