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August 22, 2024


Electronic instructions for use for medical devices (EU law)

By Christopher SeibAugust 22, 20242 Comments

EU 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.

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ISO 15223-1: Medical symbols and labels

By Christopher SeibAugust 22, 2024Leave a comment

The 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.  …

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