Medical 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”…
DetailsManufacturers who wish to place medical devices on the market in the EU must comply with the European Medical Device Regulation MDR. This Regulation (EU) 2017/745 on Medical Devices, as it is officially titled, also imposes requirements on notified bodies, distributors, importers, and health institutions such as hospitals. 1. Overview of the MDR requirements 1.1…
DetailsPoor instructions for use are a common cause of use errors that can result in harm to patients and users. Furthermore, instructions for use for medical devices and IVDs are subject to strict regulatory requirements. The MDR, the IVDR, the FDA and numerous standards establish specific requirements for the instructions for use. This article will…
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. We have summarized the requirements for electronic instructions for use for you. 1. Requirements for the use of electronic instructions for use According to Implementing Regulation (EU) 2021/2226,…
DetailsThe standard ISO 15223-1, regulates the symbols that manufacturers are permitted to/must use for labeling medical devices. In January 2022, the EU Commission harmonized EN ISO 15223-1 as one of relatively few standards under the MDR and added it to the list of harmonized standards. This alone makes it clear how relevant labeling has become. …
DetailsIn software development, unit testing refers to the testing of software units. However, there is no common understanding of This article provides clarity. 1. Test objects: What is tested during unit testing a) Usual understanding of software units Unit testing involves testing delimited parts of a software system. Depending on the size of these parts,…
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