You know it’s coming, but you don’t know when. Under the EU’s Medical Device Regulation (MDR) part of the auditing cycle for your medical device includes an unannounced visit once every 5 years from your Notified Body. The visit may be inevitable, but that doesn’t mean it’s straightforward.

The good news is that the unannounced visit is very similar to the scheduled visits you’ve already received. And, thanks to our internal expertise (and first-hand experience!), we know there are actions you can take to ensure it goes as smoothly as possible. To help you prepare more effectively, we’ve compiled a list of common questions and answers.

When you’re bringing a medical device to the EU market or any other country that’s adopted the EU’s Medical Device Regulation (MDR), there are two important things to factor into your compliance journey: time and cost. It can take months, or even years, to bring a medical device to market in the EU. And getting the correct certification isn’t cheap.

To get it there – and keep your product on the market – you need certification, and that requires a long-term relationship with an accredited Notified Body. As we uncover in this article, certification takes time and money, but there are actions you can take to speed up the process and keep a lid on the costs.

Developed and drafted at the same time as the Medical Device Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR) is a significant legislative framework that governs the safety and performance of in vitro diagnostic medical devices (IVDs) in the EU. IVDs are used to perform tests and experiments on biological samples (like blood, tissue, or cells) outside a living body, typically in a lab. 

IVDs help in diagnosing diseases, monitoring health conditions, or studying biological processes. For example, a blood glucose test kit that measures sugar levels in a blood sample taken from the body is an IVD. In recent times, most of the world’s population has had first-hand experience with IVDs in the form of COVID-19 test kits. For manufacturers of these IVDs, understanding and complying with the IVDR is essential.