In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by the European Parliament and Council, came into force. The regulation forms the core of European market surveillance law and will grant market surveillance authorities additional powers and strengthen the exchange of information between competent authorities. Furthermore, it seeks to uniformly [...]
CE marking indicates compliance with an EU directive so that you can market your products in the EU. It's that simple. CE marking is a voluntary conformity assessment procedure, but it is a requirement if you plan to market your product on the European market. The letters "CE" stands for Conformité Européenne [...]
Even though every medical device manufacturer does their utmost to ensure their medical devices are safe and efficient, adverse events still happen. Off-label use, installation/service issues, lack of training, and many other causes can lead to suspected medical device-associated deaths, serious injuries, and malfunctions. Every year, the Food and Drug Administration (FDA) receives hundreds [...]
Post-market surveillance and vigilance costs are overgrowing. For example, the number of reported adverse reactions has increased annually by approximately 10-15% over the past five years. In addition, costs for post-market surveillance have been growing, especially in high-risk products. What is PMS or post-market surveillance? In post-market surveillance, a drug or medical device is [...]
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 data to evaluate your device's safety, benefit, and risk in an evidence-based manner. Since the medical device literature reviews [...]
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 more than one step. When searching for info on a topic, it can be easy to lose sight of [...]
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 staff and medical writers are typically quite familiar with the clinical evaluation process, clinical evaluation report (CER), and demonstrating compliance [...]
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 asked questions about IVDR and their answers. What is IVDR? Simply put, IVDR is the new [...]
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 from the two other surveillance activities? Don't fret! Today, we are exploring post-market surveillance, market surveillance, and vigilance and telling [...]
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. Medical devices' feedback can be precious because they're often life-saving. In addition, you want to ensure that you're providing [...]
