Inhaber der Johner Institut GmbH
With PFAS, the EU plans to ban an entire class of chemicals. In doing so, it is not only threatening the supply of medical devices but also the competitiveness of EU manufacturers. After all, the assumption that manufacturers inside and outside the EU are treated equally is just one of the EU’s five misconceptions in…
DetailsMany companies consider Regulatory Intelligence so important that they create their own roles and departments for it. This article clarifies what Regulatory Intelligence is, how companies can benefit from it, and where tools can provide support. 1. What is “Regulatory Intelligence”? This includes gathering and analyzing regulatory information from various sources, including regulatory agencies, industry…
DetailsLaws and standards formulate requirements on how medical device manufacturers must define and document the development process. Notified bodies check these requirements during audits. This article on the development process provides tips on how to design the process and how to align it with other processes, such as the risk management process. 1. Development process:…
DetailsMedical software manufacturers must meet the legal requirements for software components in order to “approve” their devices. This article presents these requirements and gives seven tips on how to fulfill them quickly and easily. 1. What software components / items are There are different definitions of “software component”, also referred to as software items as…
DetailsThe terms maintenance, preventive maintenance, restoration, inspection, service, and safety inspections are not synonymous. But they all refer to activities in the life cycle of medical devices that serve the objective of ensuring the safety, performance, and effectiveness of these devices even after they have been placed on the market. Manufacturers and operators must meet…
DetailsThe Health Insurance Portability and Accountability Act (HIPAA) is a US law that establishes requirements for processing protected health data. Institutions that collect or process these data in the USA and their subcontractors must comply with HIPAA if they want to avoid sanctions. For European companies in particular, HIPAA is a regulation that is difficult to understand…
DetailsThe MDR requires medical device manufacturers to conduct Post-Market Surveillance (PMS) and thus collect PMS data. This article is intended to help clarify the regulatory requirements manufacturers must consider when collecting these PMS data. Notably, it is intended to highlight whether manufacturers need to consult an ethics committee in Europe if the data arise from…
DetailsThe digital transformation of notified bodies will transform the medical device ecosystem over the next few years. This article describes 1. Drivers of the digital transformation of notified bodies The period in which notified bodies, as an oligopoly, were allowed to pick and choose customers and determine prices and conditions is coming to an end.…
DetailsPractical guidance based on the experience of the Johner Institute, Oliver Hilgers, and Stefan Bolleininger The discussion about class I software continues to rage. This article provides guidance regarding the MDR rules for the classification of medical software. 1. Background a) Relevance of the issue Whether or not medical software counts as class I software is…
DetailsRegulators still publish laws and regulations as texts. Just as it has been for thousands of years. Regulation as Code represents a radical paradigm shift away from this practice. Is it possible to transform laws into algorithms? Why should anyone want to do this? How should you get ready for this as a regulator, manufacturer, authority, or…
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