December 6, 2022
The In Vitro Diagnostic Regulation (IVDR; 2017/746) started its staggered implementation in May 2022. Compared to the In Vitro Diagnostic Directive (IVDD; 98/79/EC), post-market surveillance and vigilance have been given their due in the IVDR; [...]
July 5, 2022
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 [...]
June 28, 2022
The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019 9 update published [...]
October 4, 2022
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, [...]
September 27, 2022
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 [...]
September 20, 2022
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 [...]
September 12, 2022
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 [...]
September 6, 2022
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 [...]
August 30, 2022
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 [...]
August 23, 2022
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. [...]
August 16, 2022
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 [...]
August 9, 2022
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 [...]