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. 

There are many reasons why your medical device company might choose to engage a regulatory consultant at short notice. You could be facing unexpected regulatory challenges, critical deadlines, or compliance issues that might negatively impact product approval, market access, or ongoing operations.
Here at Peercode, we provide rapid response consultancy that delivers fast, expert guidance to medical device companies needing urgent assistance to meet regulatory requirements. Here’s what that looks like and why time matters in medical device regulation.

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.