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…
DetailsIn a standard operating procedure (SOP), companies define their processes, for example how they develop medical devices or provide services. Standards such as ISO 9001 and ISO 13485 require standard operating procedures. Companies can define these specifications in their quality management manual directly or in independent documents.
DetailsMost manufacturers use harmonized standards to demonstrate the conformity of their devices with the general safety and performance requirements. This also applies to medical device manufacturers, for example.
The 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…
DetailsThe incorporation of AI in medical devices has made great strides, for example, in the diagnosis of disease. Manufacturers of devices with machine learning face the challenge of having to demonstrate compliance of their devices with the regulations. Even if you know the law – what are the standards and best practices to consider in…
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 correct and precise formulation of the intended purpose of medical devices and in vitro diagnostic medical devices (IVD) is crucial for their successful development and approval. However, even the definitions of terms and the distinction between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…
DetailsThe classification of in-vitro diagnostics (IVD) can have far-reaching consequences, as it has an impact on the conformity assessment procedure, certification audits, and, thus, on market launch. To help you prevent the unnecessary allocation of your IVD product to a high-risk class, this article provides an overview of
DetailsNeither the MPG nor the MDR contain regulations on product liability, i.e., manufacturers’ liability for harm caused by defective devices. However, manufacturers should be aware that a lot of legal regulations entitle injured persons to claim compensation if a defective medical device causes harm to a patient, user, or third party. Liability may result, for example,…
DetailsAnytime you want to launch a medical device on the market, you quickly come to the question of which legal regulations you have to comply with. This article will give you answers and present the seven steps to quickly place your devices on the market in compliance with the law.
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