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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 […]

MDSAP – Medical Device Single Audit Program: an Audit for the FDA and Four other Authorities In this blog post, we explain what MDSAP is all about. We will explain its structure, process, and important aspects of preparing for this audit. Are you interested in our services in the area of the Medical Device Single

FDA registration of medical devices Many of you will have heard that FDA approval is necessary to legally sell medical devices in the USA. These procedures include a Premarket Notification 510(k) or a Premarket Approval (PMA). There is also another, lesser-known procedure. The so-called De Novo Program of the FDA. But “only” having product approval

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

EU Declaration of Conformity for Medical Devices and IVDs What is an EU Declaration of Conformity? Regarding medical devices and IVDs, the EU Declaration of Conformity states that the requirements specified in the MDR or IVDR for the product concerned have been met. For this purpose, the manufacturer issues the EU Declaration of Conformity under

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

Medical Device Vigilance What Does Vigilance Mean? The term vigilance means constant attention. For medical devices and IVDs, it is about manufacturers implementing a vigilance system that enables them to identify and report reportable or serious incidents and trends from collected data. For example, the data is collected as part of complaint handling or post-market

Fundamentals – Quality Management in Medical Technology What is the Purpose of a Quality Management System? The fundamental idea is to establish a system that enables a continuous, iterative increase in quality. This system is designed to prevent a previously achieved quality level from being lost. It should provide a framework that systematically addresses errors