Lukas Losigkeit

The different classes Medical devices and accessories are classified in the European Union in accordance with the MDR, or more precisely in accordance with Annex VIII of Regulation (EU) 2017/745. The classification is based on 22 rules as well as relevant definitions and implementing provisions. The underlying idea is to differentiate medical devices according to […]

Fundamentals of Post-market Surveillance What is Post-market Surveillance? Post-market Surveillance (PMS) is the English term for the surveillance of medical devices and in-vitro diagnostics (IVDs) after they have been placed on the market. Manufacturers of medical devices and IVDs operate in a strictly regulated environment. This is important because medical technology involves human lives. It’s

GCP, Good Clinical Practice – Good Clinical Practice According to ICH E6 (R2) and ISO 14155 Good Clinical Practice – GCP – Good Clinical Practice Another term related to GxP. But what’s behind it? Good Clinical Practice (GCP) is based on internationally recognized ethical and scientific standards in the field of clinical trials. It provides

PMCF: Post-market Clinical Follow-Up – Clinical Post-Market Follow-Up The MDR introduces a number of new terms and abbreviations. One of them is PMCF – Post-market clinical follow-up. In German: The clinical post-market follow-up. But what exactly is it? In this article, we will explain what this term means. You will also learn for which products

Basics – IVDs in Medical Technology What are IVDs? In Vitro Diagnostic devices (IVDs) are a subgroup of medical devices. In vitro means that diagnostics are performed based on organic processes outside the living organism. Conversely, the term “in vivo” means that something takes place within the living organism. By definition, IVDs are intended for