Inhaber der Johner Institut GmbH
This article examines the AI Act’s applicability to manufacturers of medical devices and IVD that do not place AI-based devices on the market. Among other things, it answers the question of whether a manufacturer must comply with the AI Act if he uses ChatGPT or develops an AI system that classifies customer feedback for his…
DetailsThe EU AI Act has been published. Many manufacturers of medical devices and IVD, as well as other healthcare players, are faced with the major task of understanding the 140+ pages of legal text and complying with the requirements. Note: Infringements/violations of the AI Act are punishable by a fine of up to 7% of…
DetailsRegulation (EU) 2025/327 on the European Health Data Space (EHDS for short) is another European regulation that may affect medical device and IVD manufacturers. This article explains what this regulation requires and what these manufacturers have to do by when, as well as the possible advantages of the EHDS and the EHDS Regulation.
DetailsThe DAkkS, the German Accreditation Body, is Germany’s national accreditation authority.
The 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…
DetailsAccessibility refers to the design of products and services that can also be used by people with physical limitations. The term “products and services” encompasses both physical and digital products and services. This also includes medical devices (physical devices, apps, other standalone software). This article explains which accessibility requirements manufacturers of medical devices should be…
DetailsOn September 14, 2024, the new version of the German Health Interoperability Governance Regulation (or IOP Governance Regulation, or GIGV for short) came into force. The German Ministry of Health published a draft bill (only available in German) containing the recitals on April 24 of that year. This version of the GIGV will replace the…
DetailsCompanies need to master the digital transformation quickly and successfully. This also applies to medical device manufacturers because, after all, their future depends on it. Many companies make severe mistakes during this transformation (see section 4). This article provides managers with a quick overview of the possibilities of digital transformation and gives seven tips to make it…
DetailsWhat is the difference between verification and validation, and how are these terms defined? Even standards and regulations use the terms incorrectly or misleadingly. This article
DetailsThe EU Data Act came into force in December 2023. It aims to create a new legal framework for handling data that will not only affect US tech giants. The EU Data Act will have an impact on many companies that process data, including medical device manufacturers. This article will help you assess:
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