Month: September 2024
The FDA eStar Program: Obligation or Opportunity?
With the eStar program The FDA wants to increase the efficiency of approval processes (e.g. the 510(k) process) through digitalization. The Johner Institute is working with the FDA to further develop eStar. In this article you will find out how far-sighted this approach is and whether you should or even need to take part in…
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ISO 15223-1: Medical symbols and markings
ISO 15223-1 regulates the symbols that manufacturers can (or must) use to label medical devices. In January 2022, the EU Commission harmonized EN ISO 15223-1 as one of the 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. Read…
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Electronic instructions for the use of medical devices
EU Regulation 2017/745 (MDR) specifies the general requirements for instructions for use (IFU for short). The Implementing Regulation (EU) 2021/2226 regulates whether it can also be available in electronic format (eIFU). We have summarized the requirements of the electronic operating instructions for you. 1. Requirements for using the electronic operating instructions According to Implementing Regulation…
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