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 probability of software defects is difficult to estimate. It’s so difficult that the “old” DIN EN IEC 62304:2006 wrote: “However, there is no agreement on how to determine the probability of the occurrence of software failures using traditional statistical methods.” The standard concluded that “the probability of such a malfunction must be assumed to…
DetailsIEC 62366-1 uses the concept of (hazard-related) use scenario. The FDA uses the concept of critical (user) tasks. In development, one works with use cases and user stories. This diversity of terms makes a common understanding difficult. However, this is necessary to create consistent and legally compliant usability files and to avoid regulatory problems. This…
DetailsThe cybersecurity standard IEC 81001-5-1 focuses on how IT security needs to be taken into account in the software life cycle. As a special standard for health software, it supplements IEC 82304-1 and IEC 62304 among others, and can close gaps that urgently need to be closed. The EU is currently planning to harmonize IEC…
DetailsLaws and standards require organizations to prepare a risk management report. Notified bodies and authorities examine these reports intensively because risk management is a key regulatory requirement. Therefore, it is important (not only) for manufacturers to prepare precise, complete, and correct risk management reports. This article provides assistance in this regard.
DetailsSpecial authorizations are a concept of the MDR (Article 59). In this way, the legislator wants to create a possibility to place medical devices on the market in emergency or exceptional cases, even without having gone through a complete or successful conformity assessment procedure. Special authorizations should not be confused with concessions and exemptions under…
DetailsBoth the MDR and IVDR introduce the concept of Common Specifications.
In May 2016, the German version of IEC 60601-1-2:2014 (Edition 4) was published as DIN EN 60601-1-2:2016 with the title “Electromagnetic disturbances – Requirements and tests.” At the end of 2020, a new version of this “EMC standard” – modified by Amendment 1 and called Edition 4.1 – was published.
DetailsThe MDR contains the Classification Rule 11. This rule is especially for software. The Rule 11 has serious implications: it bears the potential to further undermine Europe’s innovation capacity. Manufacturers should familiarize themselves with the MDCG‘s interpretation to avoid misclassifying software and to be able to follow the reasoning of notified bodies and authorities. This article…
DetailsThe Medical Device Coordination Group (MDCG) has drafted a guidance document that describes how manufacturers should place their class 1 medical devices on the market in order to comply with the MDR. The title of the document is “Guidance Notes for Manufacturers of Class I Medical Devices”. This article provides a summary of the document and gives…
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…
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