Discover new articles every week on the topics of regulatory affairs (including international approval and FDA approval), QM systems (e.g., ISO 13485), risk management (ISO 14971), software development (IEC 62304), IT security, clinical evaluation, usability engineering (IEC 62366-1), and systems engineering (including IEC 60601-1, ISO 10993) - also for IVD medical devices.
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Legal Requirements and Practical Implementation under MDR/IVDR EU Authorized Representatives are not only subject to the legal requirements of the MDR and IVDR. They are also liable for violations of medical device law. This expert article provides practical answers to all regulatory questions relating to the EU-REP with specific recommendations for action from the leading consulting firm for…
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:
DetailsThe IEC 61010 series of standards specifies safety requirements for electrical equipment used for measurement, control, regulation, and laboratory use. The general standard IEC 61010-1 and the particular standards of the IEC 61010-2 series describe the state of the art and thus serve IVD manufacturers as a means of demonstrating compliance with the general safety…
DetailsTrade goods in the medical device sector can become a regulatory trap for distributors. The line between distributor and manufacturer under the MDR and IVDR is thinner than many people think, with potentially costly legal consequences.
The FDA sets clear requirements for human factors engineering (HFE) and usability engineering of medical devices. This article provides a comprehensive overview of the FDA’s usability requirements and shows you how to successfully implement them in your product development.
DetailsEU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). Whether they can also be provided in electronic form (eIFU) is regulated by Implementing Regulation (EU) 2021/2226. It was revised by Implementing Regulation (EU) 2025/1234. A consolidated version is also available now. We have summarized the requirements for electronic instructions for use for you.
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…
DetailsMedical device cybersecurity is a focus not only for the FDA but also for other legislators and authorities, both in the US and other markets. This is understandable The USA has added requirements for cyber devices to the Food, Drug & Cosmetic Act (FD&C), and the FDA has published several guidance documents on cybersecurity, which…
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.
DetailsSoftware as medical device (SaMD) refers to (independent) standalone software that is a medical device but not part of one. It should not be confused with medical device software as defined by the EU. As a manufacturer, when do you have to qualify software as medical device, and when as medical device software? Find out…
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