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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The risk management plan is one of the most important documents in technical documentation. Accordingly, authorities and notified bodies examine this plan intensively. However, it is not only from a regulatory perspective that medical device manufacturers benefit from a precise risk management plan. This article 1. What a risk management plan is In a risk…
DetailsMDCG published guideline MDCG 2023-4 in October 2023 entitled “Medical Device Software (MDSW) – Hardware combinations – Guidance on MDSW intended to work in combination with hardware or hardware components.” Criticism 1: Unclear scope of MDCG 2023-4 The title gives the impression that (all) types of combinations of hardware and Medical Device Software (MDSW) are…
DetailsHow to meet PMCF regulatory requirements as quickly as possible Post-Market Clinical Follow-up is increasingly being criticized by the notified bodies. And this is after the manufacturers have successfully mastered the hurdle before: the initial clinical evaluation. This article provides manufacturers of medical devices with 1. PMCF: The basics a) Objective and definition The MDR…
DetailsBoth the FDA and IEC 62304 recognize software developed by third parties. They refer to Off-the-Shelf Software (OTS) and Software Of Unknown Provenance (SOUP). What is the difference between OTS and SOUP? What do they have in common? What legal requirements do they have to meet? This article provides answers. 1. SOUP and OTS: definition…
DetailsMedical devices are increasingly based on closed-loop systems. “Closed-loop systems” are also mentioned in the Medical Device Regulation (MDR). In this article you will learn what closed-loop systems are, where they are used in medicine, and what regulatory requirements they need to meet. The article also reveals how you can save several hundred euros buying the…
DetailsThe term “predicate device” most often comes up in the context of FDA 510(k) clearances. However, the FDA does not define this term. It does, however, define what “substantial equivalence” is. Sounds complicated? Demonstrating equivalence is by no means only relevant in the FDA context. That’s why this article provides clarity – especially but not…
Details510(k) clearance is the primary procedure for obtaining marketing clearance in the United States. It is also referred to as Premarket Notification (PMN). This article provides a quick overview of the procedure and the documents that must be submitted. 1. General information on the 510(k) clearance by the FDA In contrast to the European jurisdiction…
DetailsFor manufacturers, the answer to whether and when clinical studies are necessary when using artificial intelligence in medical devices is relevant. After all, the duration and cost of bringing these devices to market depend on this. The good news in advance: there are cases where manufacturers can avoid clinical studies for devices with AI. This…
DetailsThe classification of whether a device is a medicinal product or a substance-based medical device has far-reaching regulatory consequences. This classification is so demanding that there are regular disputes with authorities and notified bodies, and in 2023, even the European Court of Justice had to rule on the matter. This article helps manufacturers, authorities, and…
DetailsThe 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…
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