ISO 15223-1 or ISO 980 The two standards, ISO 980 and ISO 15223-1, regulate the symbols that manufacturers are permitted to use for labeling medical devices. In November 2017, the EU Commission harmonized ISO 15223-1 and added it to the list of harmonized standards. It thus replaces ISO 980 as the standard. The discussion of…
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,…
DetailsBoth European and U.S. regulations place requirements on the labeling. However, the two legal systems do not understand the term entirely identically. Even the spelling differs: labeling in the USA, labelling in Europe. In this article, you will learn what you need to keep in mind in each case when it comes to labeling. Speaking…
DetailsISO 20417:2021 Medical devices – Information to be supplied by the manufacturer establishes requirements for the general information that manufacturers have to supply with their medical devices and IVD devices. The authors have succeeded in presenting the criteria in a clear and comprehensible manner. ISO 20417:2021 is also on the list of standards to be…
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