Accessibility 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…
DetailsThe system architecture describes the components of a (medical) device and how these components interact with each other via interfaces. For standalone software, the system architecture and software architecture coincide. 1. Documentation of the system architecture a) Notation language The documentation should reveal the individual components and their interaction. It has been proven that using…
DetailsIn December 2021, the EU extended the transitional periods of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) (Regulation 2022/112). In March 2023, the European Commission decided to abolish the “sell-off period” for IVDs that comply with Directive 98/79/EC (IVDD) (Regulation 2023/607). In January 2024, the European Commission published a proposal to amend the IVDR, which further extends…
DetailsOrphan medical devices are medical devices (and IVDs) for small patient groups. The development of these niche products is often not profitable for manufacturers. As a result, particularly vulnerable groups, such as children, do not always receive adequate medical care. This article shows possible solutions and classifies the guideline MDCG 2024-10. 1. Orphan medical device:…
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…
DetailsMedical device manufacturers must determine the severity of possible harm to assess the risks posed by their devices. What sounds simple is very challenging in practice. This article assists in determining and documenting the severity of harm in accordance with ISO 14971. 1. Basics a) Definition ISO 14971, the standard for risk management of medical…
DetailsRegulations such as the MDR require proof of the biocompatibility of all materials that come, directly or indirectly, into contact with patients or users. A test-based biocompatibility assessment provides reference data that provides a very good basis in the event of unexpected problems and that helps to quickly and directly identify unknown causes. However, there…
DetailsThe SSCP (Summary of Safety and Clinical Performance) is not the only report that the MDR requires from many medical device manufacturers. In terms of content, the SSCP even overlaps with the PSUR and the PMS reports. The IVDR places almost identical requirements on the SSP (Summary of Safety and Performance). How do all these…
DetailsAQL stands for Acceptable Quality Level and is sometimes translated as “permitted reject rate.” The AQL determines when a batch of parts or products is rejected or accepted based on a random sample inspection. However, auditors regularly no longer accept the AQL. What to do? This article provides answers. 1. Who is affected by the…
DetailsISO 14971 defines the terms “hazard” and “hazardous situation.” Nevertheless, medical device manufacturers often find it difficult to assign concrete cases to either of the two categories. This article provides help. 1. Definition of hazard and hazardous situation The ISO 14971 defines: The standard provides examples of hazards (see Fig. 1): The example of “information”…
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