The EU plans to replace the existing Directive 2006/66/EC with the new EU Regulation on batteries and waste batteries (“Battery Regulation”). This article clarifies, 1. Background a) Objective With the Battery Regulation, the EU aims to modernize the legal framework for batteries. The regulation is a response to calls for a comprehensive revision and expansion…
DetailsThe term “sampling kit” is not defined by the IVDR or any other regulation. Nevertheless, there are (indirect) regulatory requirements that IVD manufacturers and medical laboratories must be aware of and consider. The requirements depend on the particular constellation. This article presents five constellations. It provides clarity and helps to avoid regulatory hassles and minimize…
DetailsCombination products consist of the combination of a medical device and a medicinal product. Since both medical device and medicinal product law could be applicable here, there are some special features that must be taken into account for products of this type. In this article, you learn more about 1. What are combination products? a)…
DetailsWith the eSTAR Program, the FDA aims to increase the efficiency of approval procedures (e.g., the 510(k) procedure) through digitalization. This article tells you how forward-looking this approach is and whether you should or even must take part. 1. What is the eSTAR Program? The eSTAR Program enables medical device manufacturers to submit their approval…
DetailsThe FDA describes its requirements for Human Factors Engineering in two documents: This article What the FDA calls “Human Factors Engineering” (HFE), IEC 62366-1 calls “Usability Engineering“. The FDA defines the term as follows: 1. How the FDA’s “Human Factors Guidances” interact In the introduction to the document “Content of Human Factors Information in Medical…
DetailsIn order to evaluate the biocompatibility of standard materials, medical device manufacturers can, in most cases, avoid animal testing. In recent years, the Johner Institute had always succeeded in showing alternatives to animal testing, even when authorities and notified bodies demanded them. Learn here how you can contribute to animal welfare, save money, and bring…
DetailsA German medical technology industry analysis from 2020 estimated the market for medical devices in South Korea at USD 6.7 billion. Due to an annual growth rate of imports of (estimated) 10% and the increasing aging of the population with a simultaneous increase in basic medical care, the South Korean market is expected to grow…
DetailsOnly through clinical evidence – real evidence – can manufacturers prove their medical devices’ safety, performance, and benefit. But when is proof valid enough? In other words, when is there sufficient clinical evidence for authorities and notified bodies to accept? This article answers the questions and provides a compact introduction to the topic of “clinical…
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