EU MDR

The European Medical Device Regulation (MDR) outlines the requirements for the literature review needed for the clinical evaluation of medical devices. You need a robust process for performing your literature review and finding clinical [...]

The research process is often thought of as a linear, straightforward path. You begin with a question and then proceed to find the answer. But, in reality, research is a messy process that often involves [...]

Literature reviews are an essential part of the clinical evaluation process for medical devices. The clinical evaluation report assesses a medical device's benefit-risk profile to ensure its continued safety, efficiency, and compliance. Most regulatory [...]

The In Vitro Diagnostic Regulation has held the center of the medical device manufacturers' community's attention for a while now. While most manufacturers know of it, many details can still be confusing. Here are the [...]

Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when it comes to market surveillance, what exactly makes it different from post-market surveillance? And why is vigilance a separate entity [...]

Feedback is important. No matter what you're selling, if you want to improve, it's crucial to know what customers think of your product and how they feel about the experience they have with it. [...]

Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report (CER) for medical devices can be tricky. Regulations and guidelines change, as does the attitude of the notified bodies. A [...]

EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything but easy. With the slow but steady transfer of MDD to MDR, various aspects of requirements [...]

While post-market clinical follow-up (PMCF) played a part in the MDD (Directive 93/42/EEC), the updated Medical Device Regulation (MDR, 2017/745) introduced stricter rules for post-market surveillance, including post-market clinical follow-up. The increase in clinical [...]

Until January 2021, medical devices in the UK were regulated under the European regulatory framework. After Brexit and the withdrawal of the UK from the EU, the UK government has had to put a full [...]

The MDR is a sweeping reform of medical device regulation in Europe that aims to strengthen safety and quality. Recently, the provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVD) have [...]

Post-market surveillance is a significant part of any medical device manufacturer's responsibilities, especially since the European Medical Device Regulation (MDR, 2017/745) implementation put an extra focus on post-market surveillance and vigilance activities. Today we are [...]